Biosimilar: Biologics Price Competition and Innovation Act of 2009
Meeting on Friday, December 16, 2011, from 9 a.m. to 1 p.m.
Agenda: FDA is announcing a public meeting to discuss proposed recommendations for a user fee program for biosimilar biological products (biosimilars user fee program) for FYs 2013 through 2017.
Wednesday, December 14, 2011
Wednesday, November 30, 2011
Medical Devices Dispute Resolution Panel of the Medical Devices Advisory Committee
Medical Devices Dispute Resolution Panel of the Medical Devices Advisory Committee
Committee Meeting on December 14, 2011, from 8 a.m. to 6 p.m
Agenda: This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The topic to be discussed is the Center for Device and Radiological Health''s (CDRH''s) denial of a premarket approval application (PMA) for the SEDASYS computer-assisted personalized sedation system (SEDASYS) submitted by Ethicon Endo-Surgery Inc. (EES)--the sponsor for SEDASYS. The meeting will be open to the public.
Committee Meeting on December 14, 2011, from 8 a.m. to 6 p.m
Agenda: This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The topic to be discussed is the Center for Device and Radiological Health''s (CDRH''s) denial of a premarket approval application (PMA) for the SEDASYS computer-assisted personalized sedation system (SEDASYS) submitted by Ethicon Endo-Surgery Inc. (EES)--the sponsor for SEDASYS. The meeting will be open to the public.
Dermatologic and Ophthalmic Drugs Advisory Committee
Dermatologic and Ophthalmic Drugs Advisory Committee
Meeting on February 27, 2012, from 9 a.m. to 5 p.m.
Agenda: The committee will be asked to comment on the following topics related to the use of ophthalmic drug products (products intended for use in the eye): (1) Appropriate types of clinical evidence for developing anti-inflammatory drugs for the treatment of postoperative inflammation and reduction of ocular (eye) pain in patients who have undergone ocular surgery. This will include a discussion of the definition and scope of this indication as well as the types of clinical trials needed to support approval; and (2) appropriateness of marketing a single bottle of ophthalmic product for use in both eyes for postsurgical indications as it relates to the potential risk for infection. FDA’s Center for Drug Evaluation and Research would like the advisory committee to provide advice on the potential risk and approaches to mitigating that risk, including limits to fill size where appropriate
Meeting on February 27, 2012, from 9 a.m. to 5 p.m.
Agenda: The committee will be asked to comment on the following topics related to the use of ophthalmic drug products (products intended for use in the eye): (1) Appropriate types of clinical evidence for developing anti-inflammatory drugs for the treatment of postoperative inflammation and reduction of ocular (eye) pain in patients who have undergone ocular surgery. This will include a discussion of the definition and scope of this indication as well as the types of clinical trials needed to support approval; and (2) appropriateness of marketing a single bottle of ophthalmic product for use in both eyes for postsurgical indications as it relates to the potential risk for infection. FDA’s Center for Drug Evaluation and Research would like the advisory committee to provide advice on the potential risk and approaches to mitigating that risk, including limits to fill size where appropriate
Neurological Devices Panel of the Medical Devices Advisory Committee
Neurological Devices Panel of the Medical Devices Advisory Committee
Meeting on February 10, 2012, from 8 a.m. to 4:30 p.m.
Agenda: On February 10, 2012, the committee will discuss and make recommendations regarding the possible reclassification of cranial electrotherapy stimulator (CES) devices. On August 8, 2011 (76 FR 48062), FDA issued a proposed rule which, if made final, would make CES devices Class III requiring premarket approval. In response to the proposed rule, FDA received petitions under section 515(b)(2)(B) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e(b)(2)(B)) requesting a change in classification. The reclassification petitions are available for public review and comment at www.regulations.gov under docket number FDA-2011-N-0504. The committee discussion will include the existing data to support CES safety and effectiveness and whether the data are sufficient to develop special controls to support regulation of these devices under Class II.
Meeting on February 10, 2012, from 8 a.m. to 4:30 p.m.
Agenda: On February 10, 2012, the committee will discuss and make recommendations regarding the possible reclassification of cranial electrotherapy stimulator (CES) devices. On August 8, 2011 (76 FR 48062), FDA issued a proposed rule which, if made final, would make CES devices Class III requiring premarket approval. In response to the proposed rule, FDA received petitions under section 515(b)(2)(B) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e(b)(2)(B)) requesting a change in classification. The reclassification petitions are available for public review and comment at www.regulations.gov under docket number FDA-2011-N-0504. The committee discussion will include the existing data to support CES safety and effectiveness and whether the data are sufficient to develop special controls to support regulation of these devices under Class II.
Advisory Committee for Reproductive Health Drugs
Advisory Committee for Reproductive Health Drugs
Meeting on January 20, 2012, from 8 a.m. to 4:30 p.m.
Agenda: The committee will discuss the benefits and risks of new drug application 22–139, progesterone gel 8%, Columbia Laboratories, Inc., for the proposed indication of ‘‘reduction of risk of preterm birth in women with short uterine cervical length regardless of other risk factors in the mid-trimester of pregnancy.’’ The uterine cervix is the mouth of the uterus (or womb) leading into the vagina (or birth canal). The benefit/risk discussion will focus on the adequacy of the demonstration of efficacy in the U.S. population.
Meeting on January 20, 2012, from 8 a.m. to 4:30 p.m.
Agenda: The committee will discuss the benefits and risks of new drug application 22–139, progesterone gel 8%, Columbia Laboratories, Inc., for the proposed indication of ‘‘reduction of risk of preterm birth in women with short uterine cervical length regardless of other risk factors in the mid-trimester of pregnancy.’’ The uterine cervix is the mouth of the uterus (or womb) leading into the vagina (or birth canal). The benefit/risk discussion will focus on the adequacy of the demonstration of efficacy in the U.S. population.
Tobacco Products Scientific Advisory Committee
Tobacco Products Scientific Advisory Committee
Committee Meeting on January 20, 2012, from 8 a.m. to 4 p.m. (Day 3 of 3)
Agenda: As part of the Tobacco Products Scientific Advisory Committee’s required report to the Secretary of Health and Human Services, the committee will continue discussing issues related to the nature and impact of the use of dissolvable tobacco products on the public health, including such use among children. Discussion will include such topics as the composition and characteristics of dissolvable tobacco products, product use, potential health effects, and marketing.
Committee Meeting on January 20, 2012, from 8 a.m. to 4 p.m. (Day 3 of 3)
Agenda: As part of the Tobacco Products Scientific Advisory Committee’s required report to the Secretary of Health and Human Services, the committee will continue discussing issues related to the nature and impact of the use of dissolvable tobacco products on the public health, including such use among children. Discussion will include such topics as the composition and characteristics of dissolvable tobacco products, product use, potential health effects, and marketing.
Tobacco Products Scientific Advisory Committee
Tobacco Products Scientific Advisory Committee
Committee Meeting on January 19, 2012, from 8 a.m. to 5 p.m. (Day 2 of 3)
Agenda: As part of the Tobacco Products Scientific Advisory Committee’s required report to the Secretary of Health and Human Services, the committee will continue discussing issues related to the nature and impact of the use of dissolvable tobacco products on the public health, including such use among children. Discussion will include such topics as the composition and characteristics of dissolvable tobacco products, product use, potential health effects, and marketing.
Committee Meeting on January 19, 2012, from 8 a.m. to 5 p.m. (Day 2 of 3)
Agenda: As part of the Tobacco Products Scientific Advisory Committee’s required report to the Secretary of Health and Human Services, the committee will continue discussing issues related to the nature and impact of the use of dissolvable tobacco products on the public health, including such use among children. Discussion will include such topics as the composition and characteristics of dissolvable tobacco products, product use, potential health effects, and marketing.
Tobacco Products Scientific Advisory Committee
Tobacco Products Scientific Advisory Committee
Committee Meeting on January 18, 2012, from 8 a.m. to 5 p.m. (Day 1 of 3)
Agenda: As part of the Tobacco Products Scientific Advisory Committee’s required report to the Secretary of Health and Human Services, the committee will continue discussing issues related to the nature and impact of the use of dissolvable tobacco products on the public health, including such use among children. Discussion will include such topics as the composition and characteristics of dissolvable tobacco products, product use, potential health effects, and marketing.
Committee Meeting on January 18, 2012, from 8 a.m. to 5 p.m. (Day 1 of 3)
Agenda: As part of the Tobacco Products Scientific Advisory Committee’s required report to the Secretary of Health and Human Services, the committee will continue discussing issues related to the nature and impact of the use of dissolvable tobacco products on the public health, including such use among children. Discussion will include such topics as the composition and characteristics of dissolvable tobacco products, product use, potential health effects, and marketing.
Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee
Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee
Committee Meeting on January 11, 2012, from 8 a.m. to 6 p.m.
Agenda: On January 11, 2012, the committee will discuss, make recommendations, and vote on information related to the premarket approval application, sponsored by Torax Medical, Inc., for the LINX Reflux Management System, a sterile, single use, surgically placed device used to treat the symptoms associated with gastroesophageal reflux disease.
Committee Meeting on January 11, 2012, from 8 a.m. to 6 p.m.
Agenda: On January 11, 2012, the committee will discuss, make recommendations, and vote on information related to the premarket approval application, sponsored by Torax Medical, Inc., for the LINX Reflux Management System, a sterile, single use, surgically placed device used to treat the symptoms associated with gastroesophageal reflux disease.
Tuesday, November 15, 2011
Advisory Committee for Reproductive Health Drugs
Advisory Committee for Reproductive Health Drugs
Meeting on January 20, 2012, from 8 a.m. to 4:30 p.m.
AGENDA DESC Agenda: The committee will discuss the benefits and risks of new drug application 22–139, progesterone gel 8%, Columbia Laboratories, Inc., for the proposed indication of ‘‘reduction of risk of preterm birth in women with short uterine cervical length regardless of other risk factors in the mid-trimester of pregnancy.’’ The uterine cervix is the mouth of the uterus (or womb) leading into the vagina (or birth canal). The benefit/risk discussion will focus on the adequacy of the demonstration of efficacy in the U.S. population.
Meeting on January 20, 2012, from 8 a.m. to 4:30 p.m.
AGENDA DESC Agenda: The committee will discuss the benefits and risks of new drug application 22–139, progesterone gel 8%, Columbia Laboratories, Inc., for the proposed indication of ‘‘reduction of risk of preterm birth in women with short uterine cervical length regardless of other risk factors in the mid-trimester of pregnancy.’’ The uterine cervix is the mouth of the uterus (or womb) leading into the vagina (or birth canal). The benefit/risk discussion will focus on the adequacy of the demonstration of efficacy in the U.S. population.
Wednesday, October 26, 2011
Oncologic Drugs Advisory Committee
Oncologic Drugs Advisory Committee
Meeting on December 7, 2011, from 8 a.m. to 5 p.m.
Agenda: On December 7, 2011, during the morning session, the committee will discuss new drug application (NDA) 202324, with the proposed trade name Inlyta (axitinib) tablets, application submitted by Pfizer, Inc. The proposed indication (use) for this product is for the treatment of patients with advanced renal cell carcinoma (kidney cancer). During the afternoon session, the committee will discuss new drug application (NDA) 202799, with the established name peginesatide injection, application submitted by Affymax, Inc. The proposed indication (use) for this product is for the treatment of anemia associated with chronic renal failure in adult patients on dialysis.
Meeting on December 7, 2011, from 8 a.m. to 5 p.m.
Agenda: On December 7, 2011, during the morning session, the committee will discuss new drug application (NDA) 202324, with the proposed trade name Inlyta (axitinib) tablets, application submitted by Pfizer, Inc. The proposed indication (use) for this product is for the treatment of patients with advanced renal cell carcinoma (kidney cancer). During the afternoon session, the committee will discuss new drug application (NDA) 202799, with the established name peginesatide injection, application submitted by Affymax, Inc. The proposed indication (use) for this product is for the treatment of anemia associated with chronic renal failure in adult patients on dialysis.
Psychopharmacologic Drugs Advisory Committee
Psychopharmacologic Drugs Advisory Committee
Meeting on December 12, 2011, from 8 a.m. to 5 p.m.
Agenda: The committee will discuss safety and efficacy issues with new drug application (NDA) 022549, ADASUVE (loxapine) inhalation powder, Alexza Pharmaceuticals, Inc., for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults. Particular issues for discussion are concerns regarding pulmonary safety.
Meeting on December 12, 2011, from 8 a.m. to 5 p.m.
Agenda: The committee will discuss safety and efficacy issues with new drug application (NDA) 022549, ADASUVE (loxapine) inhalation powder, Alexza Pharmaceuticals, Inc., for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults. Particular issues for discussion are concerns regarding pulmonary safety.
Tuesday, October 18, 2011
Circulatory System Devices Panel of the Medical Devices Advisory Committee
Circulatory System Devices Panel of the Medical Devices Advisory Committee
Meeting on December 8, 2011, from 8 a.m. to 6 p.m. (Day 2 of 2)
Agenda: On December 8, 2011, the committee will discuss, make recommendations, and vote on information related to the PMA for the CardioMEMS HF Pressure Measurement System (HF System) sponsored by CardioMEMS, Inc. The CardioMEMS HF System is a permanently implantable pressure measurement system designed to provide daily pulmonary arterial pressure measurements including systolic, diastolic, and mean pulmonary artery pressure. These measurements are used to guide treatment of congestive heart failure. The system consists of the following:
Implantable Sensor-The Pressure Sensor is 15 millimeters (mm) in length, 3.41 mm in width and is 2 mm thick, consisting of a three dimensional coil and pressure sensitive capacitor encased between two wafers of fused silica. The coil (inductor) electromagnetically couples to the Sensor and allows the remote measurement of the resonant frequency of the LC circuit. This allows for wireless communication with the Sensor and eliminates the need for an onboard source of energy, such as a battery.
Delivery System-The Delivery System allows the placement of the Pressure Sensor within the distal pulmonary artery. There are two versions of the Delivery System. The first includes a hydrophilic coating on the distal portion of the catheter shaft and the second has no coating on the catheter shaft. Both delivery catheters have a usable length of 120 centimeters and are compatible with a 0.018" guidewire. The Delivery System (with HF Sensor) is introduced over a guide wire through an 11Fr sheath. Tether wires connect the Sensor to the Delivery System until the physician determines that the Sensor is properly positioned within the distal pulmonary artery. Once the Sensor is in position, the tether wires are withdrawn, releasing the Sensor.
Electronics Unit (Interrogator) and database-The Electronics Unit contains hardware and software to acquire and process signals from the sensor, provides a user-friendly system interface for both patients and clinicians, and transfers PA measurements to a secure database for review by medical professionals. The database is a Web-based server that contains software, which receives data transmitted from the electronics unit, and presents the data for review by medical professionals.
Meeting on December 8, 2011, from 8 a.m. to 6 p.m. (Day 2 of 2)
Agenda: On December 8, 2011, the committee will discuss, make recommendations, and vote on information related to the PMA for the CardioMEMS HF Pressure Measurement System (HF System) sponsored by CardioMEMS, Inc. The CardioMEMS HF System is a permanently implantable pressure measurement system designed to provide daily pulmonary arterial pressure measurements including systolic, diastolic, and mean pulmonary artery pressure. These measurements are used to guide treatment of congestive heart failure. The system consists of the following:
Implantable Sensor-The Pressure Sensor is 15 millimeters (mm) in length, 3.41 mm in width and is 2 mm thick, consisting of a three dimensional coil and pressure sensitive capacitor encased between two wafers of fused silica. The coil (inductor) electromagnetically couples to the Sensor and allows the remote measurement of the resonant frequency of the LC circuit. This allows for wireless communication with the Sensor and eliminates the need for an onboard source of energy, such as a battery.
Delivery System-The Delivery System allows the placement of the Pressure Sensor within the distal pulmonary artery. There are two versions of the Delivery System. The first includes a hydrophilic coating on the distal portion of the catheter shaft and the second has no coating on the catheter shaft. Both delivery catheters have a usable length of 120 centimeters and are compatible with a 0.018" guidewire. The Delivery System (with HF Sensor) is introduced over a guide wire through an 11Fr sheath. Tether wires connect the Sensor to the Delivery System until the physician determines that the Sensor is properly positioned within the distal pulmonary artery. Once the Sensor is in position, the tether wires are withdrawn, releasing the Sensor.
Electronics Unit (Interrogator) and database-The Electronics Unit contains hardware and software to acquire and process signals from the sensor, provides a user-friendly system interface for both patients and clinicians, and transfers PA measurements to a secure database for review by medical professionals. The database is a Web-based server that contains software, which receives data transmitted from the electronics unit, and presents the data for review by medical professionals.
October 27th Circulatory System Devices Panel - Medtronic Ablation Frontiers Cardiac Ablation System of the Medical Devices Advisory Committee
Circulatory System Devices Panel of the Medical Devices Advisory Committee
Meeting on December 7, 2011, from 8 a.m. to 6 p.m. (Day 1 of 2)
Agenda: On December 7, 2011, the committee will discuss, make recommendations, and vote on information related to a supplement to the premarket approval application (PMA) P010031, sponsored by Medtronic, Inc. Medtronic is requesting FDA approval to expand the indications for use for all commercially available Medtronic Cardiac Resynchronization Therapy Defibrillator (CRT–D) devices covered under PMA P010031. The company has proposed the following expanded indication statement based on the results of the REVERSE and RAFT clinical studies: "Medtronic cardiac resynchronization therapy defibrillator (CRT–D) systems are indicated for heart failure patients who meet the following classification: NYHA Functional Class II who remain symptomatic despite stable, optimal medical therapy, and who have left bundle branch block (LBBB) with a QRS duration ≥120 ms, and leftventricular ejection fraction ≤30%."
Meeting on December 7, 2011, from 8 a.m. to 6 p.m. (Day 1 of 2)
Agenda: On December 7, 2011, the committee will discuss, make recommendations, and vote on information related to a supplement to the premarket approval application (PMA) P010031, sponsored by Medtronic, Inc. Medtronic is requesting FDA approval to expand the indications for use for all commercially available Medtronic Cardiac Resynchronization Therapy Defibrillator (CRT–D) devices covered under PMA P010031. The company has proposed the following expanded indication statement based on the results of the REVERSE and RAFT clinical studies: "Medtronic cardiac resynchronization therapy defibrillator (CRT–D) systems are indicated for heart failure patients who meet the following classification: NYHA Functional Class II who remain symptomatic despite stable, optimal medical therapy, and who have left bundle branch block (LBBB) with a QRS duration ≥120 ms, and leftventricular ejection fraction ≤30%."
Drug Safety and Risk Management Advisory Committee and Dermatologic and Ophthalmic Drugs Advisory Committee
Drug Safety and Risk Management Advisory Committee and Dermatologic and Ophthalmic Drugs Advisory Committee
Meeting on December 1, 2011, from 8 a.m. to 5 p.m.
Agenda: The Food and Drug Administration Amendments Act of 2007 (Public Law 110–85) requires FDA to bring, at least annually, one or more drugs with Risk Evaluation and Mitigation Strategies (REMS) with Elements to Assure Safe Use (ETASU) before its Drug Safety and Risk Management Advisory Committee (DSaRM). On December 1, 2011, the DSaRM and the Dermatologic and Ophthalmic Drugs Advisory Committees will meet in joint session to discuss REMS-related topics. During the morning session, the committees will discuss the REMS program for isotretinoin, also known as iPLEDGE, as an example of a REMS that has ETASU. During the afternoon session, the committees will discuss general issues related to the impact of REMS with ETASU on the health care system and patient access, such as how programs with ETASU can be better integratedinto existing health systems.
Meeting on December 1, 2011, from 8 a.m. to 5 p.m.
Agenda: The Food and Drug Administration Amendments Act of 2007 (Public Law 110–85) requires FDA to bring, at least annually, one or more drugs with Risk Evaluation and Mitigation Strategies (REMS) with Elements to Assure Safe Use (ETASU) before its Drug Safety and Risk Management Advisory Committee (DSaRM). On December 1, 2011, the DSaRM and the Dermatologic and Ophthalmic Drugs Advisory Committees will meet in joint session to discuss REMS-related topics. During the morning session, the committees will discuss the REMS program for isotretinoin, also known as iPLEDGE, as an example of a REMS that has ETASU. During the afternoon session, the committees will discuss general issues related to the impact of REMS with ETASU on the health care system and patient access, such as how programs with ETASU can be better integratedinto existing health systems.
Tuesday, October 11, 2011
Antiviral Drugs Advisory Committee
Antiviral Drugs Advisory Committee
Meeting on December 15, 2011, from 8 a.m. to 1 p.m. (Day 2 of 2)
AGENDA DESC Agenda: On December 14 and 15, 2011, the committee will discuss pathways for the development of drugs intended to treat variola virus infection(smallpox) in the event of an outbreak, including the use of animal models of other orthopoxviruses (the group of viruses that includes smallpox) as potential evidence of efficacy.
Meeting on December 15, 2011, from 8 a.m. to 1 p.m. (Day 2 of 2)
AGENDA DESC Agenda: On December 14 and 15, 2011, the committee will discuss pathways for the development of drugs intended to treat variola virus infection(smallpox) in the event of an outbreak, including the use of animal models of other orthopoxviruses (the group of viruses that includes smallpox) as potential evidence of efficacy.
Antiviral Drugs Advisory Committee
Antiviral Drugs Advisory Committee
Meeting on December 14, 2011, from 8 a.m. to 5 p.m. (Day 1 of 2)]
AGENDA DESC Agenda: On December 14 and 15, 2011, the committee will discuss pathways for the development of drugs intended to treat variola virus infection(smallpox) in the event of an outbreak, including the use of animal models of other orthopoxviruses (the group of viruses that includes smallpox) as potential evidence of efficacy.
Meeting on December 14, 2011, from 8 a.m. to 5 p.m. (Day 1 of 2)]
AGENDA DESC Agenda: On December 14 and 15, 2011, the committee will discuss pathways for the development of drugs intended to treat variola virus infection(smallpox) in the event of an outbreak, including the use of animal models of other orthopoxviruses (the group of viruses that includes smallpox) as potential evidence of efficacy.
General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee
General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee
Meeting on December 1, 2011, from 8 a.m. to 6 p.m.
Agenda: On December 1, 2011, the committee will discuss, make recommendations, and vote on information related to the premarket approval application, sponsored by Contura, Inc., for AQUAMID, a new material (polyacrylamide) for use as a dermal filler for aesthetic treatment of wrinkles in the face. The AQUAMID dermal filler is intended for use in midto- deep sub-dermal implantation for the aesthetic treatment of moderate to severe facial wrinkles and folds, such as the nasolabial folds.
Meeting on December 1, 2011, from 8 a.m. to 6 p.m.
Agenda: On December 1, 2011, the committee will discuss, make recommendations, and vote on information related to the premarket approval application, sponsored by Contura, Inc., for AQUAMID, a new material (polyacrylamide) for use as a dermal filler for aesthetic treatment of wrinkles in the face. The AQUAMID dermal filler is intended for use in midto- deep sub-dermal implantation for the aesthetic treatment of moderate to severe facial wrinkles and folds, such as the nasolabial folds.
Friday, October 7, 2011
Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee
Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee,
November 1, 2011, from 8 a.m. to 5:30 p.m.]
Agenda: On November 1, 2011, information will be presented regarding pediatric development plans for four products that were either recently approved by FDA, are in late stage development for an adult oncology indication, or in late stage development in pediatric patients with cancer. The subcommittee will consider and discuss issues relating to the development of each product for pediatric use and provide guidance to facilitate the formulation of Written Requests for pediatric studies, if appropriate. The four products under consideration are: (1) Sodium thiosulfate injection, application submitted by Adherex Technologies, Inc.; (2) vismodegib (GDC–0449), application submitted by Genentech, Inc.; (3) pazopanib, application submitted by Glaxo Wellcome Manufacturing Pte Ltd., Singapore doing business as GlaxoSmithKline; and (4) Medi-573 (fully human antibody to IGF–I and IGF–II), application submitted by MedImmune, LLC.
November 1, 2011, from 8 a.m. to 5:30 p.m.]
Agenda: On November 1, 2011, information will be presented regarding pediatric development plans for four products that were either recently approved by FDA, are in late stage development for an adult oncology indication, or in late stage development in pediatric patients with cancer. The subcommittee will consider and discuss issues relating to the development of each product for pediatric use and provide guidance to facilitate the formulation of Written Requests for pediatric studies, if appropriate. The four products under consideration are: (1) Sodium thiosulfate injection, application submitted by Adherex Technologies, Inc.; (2) vismodegib (GDC–0449), application submitted by Genentech, Inc.; (3) pazopanib, application submitted by Glaxo Wellcome Manufacturing Pte Ltd., Singapore doing business as GlaxoSmithKline; and (4) Medi-573 (fully human antibody to IGF–I and IGF–II), application submitted by MedImmune, LLC.
Tuesday, October 4, 2011
National Mammography Quality Assurance Advisory Committee
National Mammography Quality Assurance Advisory Committee
Meeting on November 4, 2011, from 8 a.m. to 6 p.m.
Agenda: On November 4, 2011, the committee will provide advice and recommendations on the following issues: (1) Proposed changes to the Mammography Quality Standard Act (MQSA) policies and inspection procedures; (2) accreditation body review of soft copy mammography images; and (3) reporting breast density on mammography reports and patient lay summaries. The committee will also receive updates on the MQSA program and the status of the Full Field Digital Mammography universal quality control manual.
Meeting on November 4, 2011, from 8 a.m. to 6 p.m.
Agenda: On November 4, 2011, the committee will provide advice and recommendations on the following issues: (1) Proposed changes to the Mammography Quality Standard Act (MQSA) policies and inspection procedures; (2) accreditation body review of soft copy mammography images; and (3) reporting breast density on mammography reports and patient lay summaries. The committee will also receive updates on the MQSA program and the status of the Full Field Digital Mammography universal quality control manual.
Monday, October 3, 2011
Gastrointestinal Drugs Advisory Committee
Gastrointestinal Drugs Advisory Committee,
Meeting on November 17, 2011, from 8 a.m. to 5 p.m. (Day 2 of 2)
Agenda: On November 17, 2011, the committee will provide recommendations to the Agency on the design and size of premarketing cardiovascular safety development programs necessary to support approval of products in the class of serotonin (5- hydroxytryptamine) receptor 4 agonists for the proposed indications of chronic idiopathic (of unknown cause) constipation, constipation predominant irritable bowel syndrome, gastroparesis, and gastroesophageal reflux disease that does not respond to a proton pump inhibitor.
Meeting on November 17, 2011, from 8 a.m. to 5 p.m. (Day 2 of 2)
Agenda: On November 17, 2011, the committee will provide recommendations to the Agency on the design and size of premarketing cardiovascular safety development programs necessary to support approval of products in the class of serotonin (5- hydroxytryptamine) receptor 4 agonists for the proposed indications of chronic idiopathic (of unknown cause) constipation, constipation predominant irritable bowel syndrome, gastroparesis, and gastroesophageal reflux disease that does not respond to a proton pump inhibitor.
Gastrointestinal Drugs Advisory Committee
Gastrointestinal Drugs Advisory Committee,
Meeting on November 16, 2011, from 8 a.m. to 5 p.m. (Day 1 of 2)
Agenda: On November 16, 2011, the committee will discuss the design of clinical trials to evaluate the safety, efficacy, and durability of response with repeat treatment cycles of XIFAXAN (rifaximin), by Salix Pharmaceuticals, Inc., for irritable bowel syndrome with diarrhea.
Meeting on November 16, 2011, from 8 a.m. to 5 p.m. (Day 1 of 2)
Agenda: On November 16, 2011, the committee will discuss the design of clinical trials to evaluate the safety, efficacy, and durability of response with repeat treatment cycles of XIFAXAN (rifaximin), by Salix Pharmaceuticals, Inc., for irritable bowel syndrome with diarrhea.
Anti-Infective Drugs Advisory Committee
Anti-Infective Drugs Advisory Committee,
Meeting on November 4, 2011, from 8 a.m. to 5 p.m. (Day 2 of 2)
Agenda: On November 4, 2011, the committee will discuss clinical trial design issues in the development of antibacterials for the treatment of hospital-acquired bacterial pneumonia, including ventilator-associated bacterial pneumonia, and the draft document entitled ‘‘Guidance for Industry: Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia: Developing Drugs for Treatment,’’ published November 2010 (see FDA Web site at http:// www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/ucm064980.htm)
Meeting on November 4, 2011, from 8 a.m. to 5 p.m. (Day 2 of 2)
Agenda: On November 4, 2011, the committee will discuss clinical trial design issues in the development of antibacterials for the treatment of hospital-acquired bacterial pneumonia, including ventilator-associated bacterial pneumonia, and the draft document entitled ‘‘Guidance for Industry: Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia: Developing Drugs for Treatment,’’ published November 2010 (see FDA Web site at http:// www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/ucm064980.htm)
Anti-Infective Drugs Advisory Committee
Anti-Infective Drugs Advisory Committee
Meeting on November 3, 2011, from 8 a.m. to 5 p.m. (Day 1 of 2)
Agenda: On November 3, 2011, the committee will discuss clinical trial design issues for the development of antibacterials for the treatment of community-acquired bacterial pneumonia and the draft document entitled ‘‘Guidance for Industry: Community-Acquired Bacterial Pneumonia: Developing Drugs for Treatment,’’ published March 2009 (see FDA Web site at http://www.fda.gov/ Drugs/GuidanceCompliance RegulatoryInformation/Guidances/ ucm064980.htm)
Meeting on November 3, 2011, from 8 a.m. to 5 p.m. (Day 1 of 2)
Agenda: On November 3, 2011, the committee will discuss clinical trial design issues for the development of antibacterials for the treatment of community-acquired bacterial pneumonia and the draft document entitled ‘‘Guidance for Industry: Community-Acquired Bacterial Pneumonia: Developing Drugs for Treatment,’’ published March 2009 (see FDA Web site at http://www.fda.gov/ Drugs/GuidanceCompliance RegulatoryInformation/Guidances/ ucm064980.htm)
Allergenic Products Advisory Committee
Allergenic Products Advisory Committee
Committee Meeting on October 25, 2011, from 8:30 a.m. to approximately 1:30 p.m.
Agenda: On October 25, 2011, the committee will meet in open session to hear and discuss CBER’s review of scientific and medical literature concerning the use of non-standardized allergen extracts in the diagnosis and treatment of allergic disease. FDA is announcing the availability of this report entitled ‘‘CBER’s Report of Scientific and Medical Literature and Information on Non-Standardized Allergen Extracts in the Diagnosis and Treatment of Allergic Disease’’ elsewhere in this issue of the Federal Register.
Committee Meeting on October 25, 2011, from 8:30 a.m. to approximately 1:30 p.m.
Agenda: On October 25, 2011, the committee will meet in open session to hear and discuss CBER’s review of scientific and medical literature concerning the use of non-standardized allergen extracts in the diagnosis and treatment of allergic disease. FDA is announcing the availability of this report entitled ‘‘CBER’s Report of Scientific and Medical Literature and Information on Non-Standardized Allergen Extracts in the Diagnosis and Treatment of Allergic Disease’’ elsewhere in this issue of the Federal Register.
Tuesday, September 27, 2011
Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee
Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee
Meeting on December 9, 2011, from 8 a.m. to 5 p.m. (Day 2 of 2)
Agenda: On December 9, 2011, the committees will discuss the benefits and risks of ORTHO EVRA (norelgestromin/ethinyl estradiol transdermal system), marketed by Janssen Pharmaceuticals, Inc., for the prevention of pregnancy. Specifically, the committees will discuss the possibly increased risk of thrombotic (blood clots) and thromboembolic events (blood clots that can break loose and move within the circulatory system) in users of ORTHO EVRA compared to women who use commonly prescribed birth control pills, as suggested by postmarketing studies.
Meeting on December 9, 2011, from 8 a.m. to 5 p.m. (Day 2 of 2)
Agenda: On December 9, 2011, the committees will discuss the benefits and risks of ORTHO EVRA (norelgestromin/ethinyl estradiol transdermal system), marketed by Janssen Pharmaceuticals, Inc., for the prevention of pregnancy. Specifically, the committees will discuss the possibly increased risk of thrombotic (blood clots) and thromboembolic events (blood clots that can break loose and move within the circulatory system) in users of ORTHO EVRA compared to women who use commonly prescribed birth control pills, as suggested by postmarketing studies.
Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee
Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee
Meeting on December 8, 2011, from 8 a.m. to 5 p.m. (Day 1 of 2)
Agenda: On December 8, 2011, the committees will discuss the benefits and risks of drospirenone-containing oral contraceptives in light of the emerging safety concern that the risk of venous thromboembolism (blood clots that can break loose and move within the circulatory system) associated with use of these products may be higher compared to oral contraceptives that contain the progestin, levonorgestrel. Drospirenone-containing oral contraceptives for the primary indication of pregnancy prevention include: YASMIN, YAZ (drospirenone/ethinyl estradiol tablets), BEYAZ, SAFYRAL (drospirenone/ethinyl estradiol/levomefolate calcium tablets and levomefolate calcium tablets), Bayer HealthCare, and the generic equivalents for these products.
Meeting on December 8, 2011, from 8 a.m. to 5 p.m. (Day 1 of 2)
Agenda: On December 8, 2011, the committees will discuss the benefits and risks of drospirenone-containing oral contraceptives in light of the emerging safety concern that the risk of venous thromboembolism (blood clots that can break loose and move within the circulatory system) associated with use of these products may be higher compared to oral contraceptives that contain the progestin, levonorgestrel. Drospirenone-containing oral contraceptives for the primary indication of pregnancy prevention include: YASMIN, YAZ (drospirenone/ethinyl estradiol tablets), BEYAZ, SAFYRAL (drospirenone/ethinyl estradiol/levomefolate calcium tablets and levomefolate calcium tablets), Bayer HealthCare, and the generic equivalents for these products.
Wednesday, September 21, 2011
Prescription Drug User Fee Act
Prescription Drug User Fee Act
Meeting on October 24, 2011, from 9 a.m. to 5 p.m.
Agenda: Administration (FDA) is announcing a public meeting to discuss proposed recommendations for the reauthorization of the Prescription Drug User Fee Act (PDUFA), which authorizes FDA to collect user fees and use them for the process for the review of human drug applications for fiscal years (FYs) 2013 through 2017. The legislative authority for PDUFA expires in September 2012. At that time, new legislation will be required for FDA to collect prescription drug user fees for future fiscal years. Following discussions with the regulated industry and periodic consultations with public stakeholders, the Federal Food, Drug, and Cosmetic Act (FD&C Act) directs FDA to publish the recommendations for the reauthorized program in the Federal Register, hold a meeting at which the public may present its views on such recommendations, and provide for a period of 30 days for the public to provide written comments on such recommendations. FDA will then consider such public views and comments and revise such recommendations as necessary.
Meeting on October 24, 2011, from 9 a.m. to 5 p.m.
Agenda: Administration (FDA) is announcing a public meeting to discuss proposed recommendations for the reauthorization of the Prescription Drug User Fee Act (PDUFA), which authorizes FDA to collect user fees and use them for the process for the review of human drug applications for fiscal years (FYs) 2013 through 2017. The legislative authority for PDUFA expires in September 2012. At that time, new legislation will be required for FDA to collect prescription drug user fees for future fiscal years. Following discussions with the regulated industry and periodic consultations with public stakeholders, the Federal Food, Drug, and Cosmetic Act (FD&C Act) directs FDA to publish the recommendations for the reauthorized program in the Federal Register, hold a meeting at which the public may present its views on such recommendations, and provide for a period of 30 days for the public to provide written comments on such recommendations. FDA will then consider such public views and comments and revise such recommendations as necessary.
Risk Communication Advisory Committee
Risk Communication Advisory Committee,
Meeting on November 18, 2011, from 8 a.m. to 2 p.m (Day 2 of 2)
Agenda: On November 18, 2011, the committee will discuss implications, for strategic communication, of recent theoretical developments on information use in decision making.
Meeting on November 18, 2011, from 8 a.m. to 2 p.m (Day 2 of 2)
Agenda: On November 18, 2011, the committee will discuss implications, for strategic communication, of recent theoretical developments on information use in decision making.
Risk Communication Advisory Committee
Risk Communication Advisory Committee
Meeting on November 17, 2011, from 8 a.m. to 5 p.m. (Day 1 of 2)]
Agenda: On November 17, 2011, the committee will discuss results of a literature review (as required in the Patient Protection and Affordable Care Act (Pub. L. 111–148) about communicating quantitative risk and benefit information in prescription drug promotional labeling and print advertising, and will also receive a briefing on activities in FDA’s Office of Special Health Issues.
Meeting on November 17, 2011, from 8 a.m. to 5 p.m. (Day 1 of 2)]
Agenda: On November 17, 2011, the committee will discuss results of a literature review (as required in the Patient Protection and Affordable Care Act (Pub. L. 111–148) about communicating quantitative risk and benefit information in prescription drug promotional labeling and print advertising, and will also receive a briefing on activities in FDA’s Office of Special Health Issues.
Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee
Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee
Meeting on November 2, 2011, from 8 a.m. to 3:30 p.m.
Agenda: On November 2, 2011, the subcommittee will consider and discuss regulatory, academic, and industry perspectives regarding the development of anticoagulant products (products to suppress clotting of blood) in children. Issues for discussion will include identification of strategies to encourage and facilitate studies of anticoagulants in children that will result in informative pediatric labeling, appropriate endpoints for studies of anticoagulants in pediatric patients, and the role of pharmacokinetic/ pharmacodynamic studies to support a pediatric indication for anticoagulants.
Meeting on November 2, 2011, from 8 a.m. to 3:30 p.m.
Agenda: On November 2, 2011, the subcommittee will consider and discuss regulatory, academic, and industry perspectives regarding the development of anticoagulant products (products to suppress clotting of blood) in children. Issues for discussion will include identification of strategies to encourage and facilitate studies of anticoagulants in children that will result in informative pediatric labeling, appropriate endpoints for studies of anticoagulants in pediatric patients, and the role of pharmacokinetic/ pharmacodynamic studies to support a pediatric indication for anticoagulants.
Tuesday, September 20, 2011
Tobacco Products Scientific Advisory Committee
Tobacco Products Scientific Advisory Committee
Committee Meeting on November 3, 2011, from 9 a.m. to 5 p.m.
Agenda: The committee will continue the discussions of issues related to the nature and impact of the use of dissolvable tobacco products on the public health, including such use among children, as part of TPSAC’s required report to the Secretary of Health and Human Services. Discussion will include such topics as the composition and characteristics of dissolvable tobacco products, product use, potential health effects, and marketing.
Committee Meeting on November 3, 2011, from 9 a.m. to 5 p.m.
Agenda: The committee will continue the discussions of issues related to the nature and impact of the use of dissolvable tobacco products on the public health, including such use among children, as part of TPSAC’s required report to the Secretary of Health and Human Services. Discussion will include such topics as the composition and characteristics of dissolvable tobacco products, product use, potential health effects, and marketing.
Tobacco Products Scientific Advisory Committee
Tobacco Products Scientific Advisory Committee
Committee Meeting on November 2, 2011, from 9 a.m. to 5 p.m.
Agenda: The committee will continue the discussions of issues related to the nature and impact of the use of dissolvable tobacco products on the public health, including such use among children, as part of TPSAC’s required report to the Secretary of Health and Human Services. Discussion will include such topics as the composition and characteristics of dissolvable tobacco products, product use, potential health effects, and marketing.
Committee Meeting on November 2, 2011, from 9 a.m. to 5 p.m.
Agenda: The committee will continue the discussions of issues related to the nature and impact of the use of dissolvable tobacco products on the public health, including such use among children, as part of TPSAC’s required report to the Secretary of Health and Human Services. Discussion will include such topics as the composition and characteristics of dissolvable tobacco products, product use, potential health effects, and marketing.
Circulatory System Devices Panel of the Medical Devices Advisory Committee
Circulatory System Devices Panel of the Medical Devices Advisory Committee
Meeting on October 27 2011, from 8 a.m. to 6 p.m. (Day 2 of 2]
Agenda: On October 27, 2011, the committee will discuss, make recommendations, and vote on information related to the premarket approval application for the Medtronic Ablation Frontiers Cardiac Ablation System sponsored by Medtronic, Inc. The Medtronic Ablation Frontiers Cardiac Ablation System is a catheter-based device developed for the treatment of atrial fibrillation. The system consists of the following: The Pulmonary Vein Ablation Catheter, which is designed to create lesions in the left atrium via five pairs of electrodes to isolate the pulmonary veins. It has a deflectable distal end and bidirectional steering to aid in positioning the catheter appropriately. The Multi-Array Septal Catheter, which is designed to create lesions on the septal wall of the left atrium via six pairs of electrodes. It is not steerable and is intended to be used in a transseptal approach. The Multi-Array Ablation Catheter, which is designed to create ‘‘X’’-like lesions in the left and/or right atrium via four pairs of electrodes. It has a deflectable distal segment and bidirectional steering within a single plane.
Meeting on October 27 2011, from 8 a.m. to 6 p.m. (Day 2 of 2]
Agenda: On October 27, 2011, the committee will discuss, make recommendations, and vote on information related to the premarket approval application for the Medtronic Ablation Frontiers Cardiac Ablation System sponsored by Medtronic, Inc. The Medtronic Ablation Frontiers Cardiac Ablation System is a catheter-based device developed for the treatment of atrial fibrillation. The system consists of the following: The Pulmonary Vein Ablation Catheter, which is designed to create lesions in the left atrium via five pairs of electrodes to isolate the pulmonary veins. It has a deflectable distal end and bidirectional steering to aid in positioning the catheter appropriately. The Multi-Array Septal Catheter, which is designed to create lesions on the septal wall of the left atrium via six pairs of electrodes. It is not steerable and is intended to be used in a transseptal approach. The Multi-Array Ablation Catheter, which is designed to create ‘‘X’’-like lesions in the left and/or right atrium via four pairs of electrodes. It has a deflectable distal segment and bidirectional steering within a single plane.
Circulatory System Devices Panel of the Medical Devices Advisory Committee
Circulatory System Devices Panel of the Medical Devices Advisory Committee
Meeting on October 26, 2011, from 8 a.m. to 6 p.m. (Day 1 of 2)
Agenda: On October 26, 2011, the committee will discuss, make recommendations, and vote on information related to the premarket approval application sponsored by AtriCure, Inc., for the AtriCure Synergy Ablation System to be used for the treatment of atrial fibrillation in patients who are undergoing open concomitant cardiac surgery. The AtriCure Synergy Ablation System consists of the following: The AtriCure Isolator Synergy Handpieces (models OLL2 and OSL2), which resemble surgical clamps, include a syringe-type grip handle/ actuator, connected by a cylindrical shaft to a pair of grasping jaws with electrodes on each jaw. The electrodes deliver radiofrequency (RF) energy to the tissue grasped by the jaws. The Ablation and Sensing Unit is an RF generator used to power the Isolator Synergy Handpieces. The Isolator Switch Matrix is an accessory interface module allowing the Isolator Synergy Handpieces to connect to the RF generator.
Meeting on October 26, 2011, from 8 a.m. to 6 p.m. (Day 1 of 2)
Agenda: On October 26, 2011, the committee will discuss, make recommendations, and vote on information related to the premarket approval application sponsored by AtriCure, Inc., for the AtriCure Synergy Ablation System to be used for the treatment of atrial fibrillation in patients who are undergoing open concomitant cardiac surgery. The AtriCure Synergy Ablation System consists of the following: The AtriCure Isolator Synergy Handpieces (models OLL2 and OSL2), which resemble surgical clamps, include a syringe-type grip handle/ actuator, connected by a cylindrical shaft to a pair of grasping jaws with electrodes on each jaw. The electrodes deliver radiofrequency (RF) energy to the tissue grasped by the jaws. The Ablation and Sensing Unit is an RF generator used to power the Isolator Synergy Handpieces. The Isolator Switch Matrix is an accessory interface module allowing the Isolator Synergy Handpieces to connect to the RF generator.
Wednesday, September 14, 2011
Endocrinologic and Metabolic Drugs Advisory Committee
Endocrinologic and Metabolic Drugs Advisory Committee,
Meeting on November 2, 2011, from 8 a.m. to 5:00 p.m.
Agenda: On November 2, 2011, the committee will discuss supplemental new drug applications 21–687 and 21– 445, VYTORIN (ezetimibe/simvastatin) and ZETIA (ezetimibe) tablets, respectively, MSP (Merck/Schering- Plough) Singapore Company, LLC. Simvastatin lowers lipids (fats that circulate in the bloodstream, including cholesterol) by inhibiting 3-hydroxy-3- methyl-glutaryl-CoA reductase, which is an enzyme involved in producing lipidsin the body, and ezetimibe lowers lipids by inhibiting the absorption of cholesterol from the intestine. The proposed indication (use) of ZETIA in combination with simvastatin or VYTORIN is to reduce major cardiovascular events in patients with chronic kidney disease based on the results of the Study of Heart and Renal Protection (SHARP). SHARP was a clinical trial that studied the effect of VYTORIN compared with placebo on the occurrence of major cardiovascular events in patients with chronic kidney disease who did not have a history of myocardial infarction or coronary revascularization (heart bypass surgery or opening heart vessels with a balloon or stents). The primary outcome of major cardiovascular events was defined as the first occurrence of either nonfatal myocardial infarction, cardiac death, stroke, or coronary or noncoronary revascularization (including nontraumatic amputation). The primary analysis demonstrated that assignment to VYTORIN significantly reduced the relative risk of a major cardiovascular event by 16% compared to placebo.
Meeting on November 2, 2011, from 8 a.m. to 5:00 p.m.
Agenda: On November 2, 2011, the committee will discuss supplemental new drug applications 21–687 and 21– 445, VYTORIN (ezetimibe/simvastatin) and ZETIA (ezetimibe) tablets, respectively, MSP (Merck/Schering- Plough) Singapore Company, LLC. Simvastatin lowers lipids (fats that circulate in the bloodstream, including cholesterol) by inhibiting 3-hydroxy-3- methyl-glutaryl-CoA reductase, which is an enzyme involved in producing lipidsin the body, and ezetimibe lowers lipids by inhibiting the absorption of cholesterol from the intestine. The proposed indication (use) of ZETIA in combination with simvastatin or VYTORIN is to reduce major cardiovascular events in patients with chronic kidney disease based on the results of the Study of Heart and Renal Protection (SHARP). SHARP was a clinical trial that studied the effect of VYTORIN compared with placebo on the occurrence of major cardiovascular events in patients with chronic kidney disease who did not have a history of myocardial infarction or coronary revascularization (heart bypass surgery or opening heart vessels with a balloon or stents). The primary outcome of major cardiovascular events was defined as the first occurrence of either nonfatal myocardial infarction, cardiac death, stroke, or coronary or noncoronary revascularization (including nontraumatic amputation). The primary analysis demonstrated that assignment to VYTORIN significantly reduced the relative risk of a major cardiovascular event by 16% compared to placebo.
Vaccines and Related Biological Products Advisory Committee
Vaccines and Related Biological Products Advisory Committee
Meeting on November 16, 2011, from approximately 8 a.m. to 5:30 p.m.
Agenda: On November 16, 2011, the committee will meet in open session to hear an overview of the research programs in the Laboratory of Method Development, Division of Viral Products, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, FDA. The committee will also hear an update on the evaluation of Gullian-Barre Syndrome after Influenza Vaccine among Medicare population, 2010-2011. The committee will then discuss and make recommendations on the safety and immunogenicity (surrogate endpoint) of Pneumococcal 13-valent conjugate vaccine (Diphtheria CRM197 Protein) in adults aged 50 years and older using an accelerated approval regulatory pathway.
Meeting on November 16, 2011, from approximately 8 a.m. to 5:30 p.m.
Agenda: On November 16, 2011, the committee will meet in open session to hear an overview of the research programs in the Laboratory of Method Development, Division of Viral Products, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, FDA. The committee will also hear an update on the evaluation of Gullian-Barre Syndrome after Influenza Vaccine among Medicare population, 2010-2011. The committee will then discuss and make recommendations on the safety and immunogenicity (surrogate endpoint) of Pneumococcal 13-valent conjugate vaccine (Diphtheria CRM197 Protein) in adults aged 50 years and older using an accelerated approval regulatory pathway.
Prescription Drug User Fee Act
Prescription Drug User Fee Act
Meeting on October 24, 2011, from 9 a.m. to 5 p.m.
Agenda: Administration (FDA) is announcing a public meeting to discuss proposed recommendations for the reauthorization of the Prescription Drug User Fee Act (PDUFA), which authorizes FDA to collect user fees and use them for the process for the review of human drug applications for fiscal years (FYs) 2013 through 2017. The legislative authority for PDUFA expires in September 2012. At that time, new legislation will be required for FDA to collect prescription drug user fees for future fiscal years. Following discussions with the regulated industry and periodic consultations with public stakeholders, the Federal Food, Drug, and Cosmetic Act (FD&C Act) directs FDA to publish the recommendations for the reauthorized program in the Federal Register, hold a meeting at which the public may present its views on such recommendations, and provide for a period of 30 days for the public to provide written comments on such recommendations. FDA will then consider such public views and comments and revise such recommendations as necessary.
Meeting on October 24, 2011, from 9 a.m. to 5 p.m.
Agenda: Administration (FDA) is announcing a public meeting to discuss proposed recommendations for the reauthorization of the Prescription Drug User Fee Act (PDUFA), which authorizes FDA to collect user fees and use them for the process for the review of human drug applications for fiscal years (FYs) 2013 through 2017. The legislative authority for PDUFA expires in September 2012. At that time, new legislation will be required for FDA to collect prescription drug user fees for future fiscal years. Following discussions with the regulated industry and periodic consultations with public stakeholders, the Federal Food, Drug, and Cosmetic Act (FD&C Act) directs FDA to publish the recommendations for the reauthorized program in the Federal Register, hold a meeting at which the public may present its views on such recommendations, and provide for a period of 30 days for the public to provide written comments on such recommendations. FDA will then consider such public views and comments and revise such recommendations as necessary.
Circulatory System Devices Panel of the Medical Devices Advisory Committee
Circulatory System Devices Panel of the Medical Devices Advisory Committee
Meeting on October 13, 2011, from 8 a.m. to 6 p.m.
Agenda: On October 13, 2011, the committee will discuss, make recommendations, and vote on information related to the premarket approval application (PMA) for the Cook, Inc., ZILVER–PTX Drug-Elutin Stent. The ZILVER–PTX Stent is a selfexpanding nitinol stent coated on its outer surface with the cytotoxic drug paclitaxel without any polymer, binder,or excipient at a dose density of 3 micrograms/square millimeter. The ZILVER–PTX Stent is available in diameters ranging from 5 to 10 millimeters (mm) and lengths of 20 to 80 mm and are pre-loaded onto 6 or 7 Fr 1 (diameter of 2 or 2.3 mm) delivery systems. Upon deployment, the ZILVER–PTX Stent expands to establish and maintain patency in the stented region. The proposed indications for use are: treatment of de novo or restenotic symptomatic vascular disease of the above-the-knee femoropopliteal arteries having reference vessel diameter from 4 mm to 9 mm and total lesion lengths perpatient of 280 mm.
Meeting on October 13, 2011, from 8 a.m. to 6 p.m.
Agenda: On October 13, 2011, the committee will discuss, make recommendations, and vote on information related to the premarket approval application (PMA) for the Cook, Inc., ZILVER–PTX Drug-Elutin Stent. The ZILVER–PTX Stent is a selfexpanding nitinol stent coated on its outer surface with the cytotoxic drug paclitaxel without any polymer, binder,or excipient at a dose density of 3 micrograms/square millimeter. The ZILVER–PTX Stent is available in diameters ranging from 5 to 10 millimeters (mm) and lengths of 20 to 80 mm and are pre-loaded onto 6 or 7 Fr 1 (diameter of 2 or 2.3 mm) delivery systems. Upon deployment, the ZILVER–PTX Stent expands to establish and maintain patency in the stented region. The proposed indications for use are: treatment of de novo or restenotic symptomatic vascular disease of the above-the-knee femoropopliteal arteries having reference vessel diameter from 4 mm to 9 mm and total lesion lengths perpatient of 280 mm.
Monday, September 12, 2011
Endocrinologic and Metabolic Drugs Advisory Committee
Endocrinologic and Metabolic Drugs Advisory Committee
Meeting on November 2, 2011, from 8 a.m. to 5:00 p.m.
Agenda: On November 2, 2011, the committee will discuss supplemental new drug applications 21–687 and 21– 445, VYTORIN (ezetimibe/simvastatin) and ZETIA (ezetimibe) tablets, respectively, MSP (Merck/Schering- Plough) Singapore Company, LLC. Simvastatin lowers lipids (fats that circulate in the bloodstream, including cholesterol) by inhibiting 3-hydroxy-3- methyl-glutaryl-CoA reductase, which is an enzyme involved in producing lipidsin the body, and ezetimibe lowers lipids by inhibiting the absorption of cholesterol from the intestine. The proposed indication (use) of ZETIA in combination with simvastatin or VYTORIN is to reduce major cardiovascular events in patients with chronic kidney disease based on the results of the Study of Heart and Renal Protection (SHARP). SHARP was a clinical trial that studied the effect of VYTORIN compared with placebo on the occurrence of major cardiovascular events in patients with chronic kidney disease who did not have a history of myocardial infarction or coronary revascularization (heart bypass surgery or opening heart vessels with a balloon or stents). The primary outcome of major cardiovascular events was defined as the first occurrence of either nonfatal myocardial infarction, cardiac death, stroke, or coronary or noncoronary revascularization (including nontraumatic amputation). The primary analysis demonstrated that assignment to VYTORIN significantly reduced the relative risk of a major cardiovascular event by 16% compared to placebo.
Meeting on November 2, 2011, from 8 a.m. to 5:00 p.m.
Agenda: On November 2, 2011, the committee will discuss supplemental new drug applications 21–687 and 21– 445, VYTORIN (ezetimibe/simvastatin) and ZETIA (ezetimibe) tablets, respectively, MSP (Merck/Schering- Plough) Singapore Company, LLC. Simvastatin lowers lipids (fats that circulate in the bloodstream, including cholesterol) by inhibiting 3-hydroxy-3- methyl-glutaryl-CoA reductase, which is an enzyme involved in producing lipidsin the body, and ezetimibe lowers lipids by inhibiting the absorption of cholesterol from the intestine. The proposed indication (use) of ZETIA in combination with simvastatin or VYTORIN is to reduce major cardiovascular events in patients with chronic kidney disease based on the results of the Study of Heart and Renal Protection (SHARP). SHARP was a clinical trial that studied the effect of VYTORIN compared with placebo on the occurrence of major cardiovascular events in patients with chronic kidney disease who did not have a history of myocardial infarction or coronary revascularization (heart bypass surgery or opening heart vessels with a balloon or stents). The primary outcome of major cardiovascular events was defined as the first occurrence of either nonfatal myocardial infarction, cardiac death, stroke, or coronary or noncoronary revascularization (including nontraumatic amputation). The primary analysis demonstrated that assignment to VYTORIN significantly reduced the relative risk of a major cardiovascular event by 16% compared to placebo.
Tuesday, August 16, 2011
Immunology Devices Panel of the Medical Devices Advisory Committee
Immunology Devices Panel of the Medical Devices Advisory Committee
Meeting on October 14, 2011, from 8 a.m. to 6 p.m.
Agenda: On October 14, 2011, the committee will discuss, make recommendations, and vote on a premarket approval application for the Progensa PCA3 assay sponsored by Gen-Probe, Inc. The Progensa PCA3 assay is indicated for use in conjunction with other patient information to aid in the decision for repeat biopsy in men 50 years of age or older who have had one or more previous negative prostate biopsies and for whom a repeat biopsy would be recommended based on current standard of care, before consideration of PCA3 assay results. A lower PCA3 score is associated with a decreased likelihood of a positive biopsy.
Meeting on October 14, 2011, from 8 a.m. to 6 p.m.
Agenda: On October 14, 2011, the committee will discuss, make recommendations, and vote on a premarket approval application for the Progensa PCA3 assay sponsored by Gen-Probe, Inc. The Progensa PCA3 assay is indicated for use in conjunction with other patient information to aid in the decision for repeat biopsy in men 50 years of age or older who have had one or more previous negative prostate biopsies and for whom a repeat biopsy would be recommended based on current standard of care, before consideration of PCA3 assay results. A lower PCA3 score is associated with a decreased likelihood of a positive biopsy.
The Development and Evaluation of Next-Generation Smallpox Vaccines
The Development and Evaluation of Next-Generation Smallpox Vaccines
Meeting on September 16, 2011, from 8 a.m. to 5:30 p.m.
The public workshop will: (1) Discuss regulatory challenges and approaches related to the licensure of next generation smallpox vaccines; (2) discuss the strengths and weaknesses of various animal models relative to their ability to mimic human disease that can be used to predict the effectiveness of humans; (3) discuss the most appropriate methods to bridge immunogenicity of next-generation smallpox vaccines to licensed smallpox vaccines in clinical trials; and (4) discuss viable methods of extrapolating clinical efficacy of next-generation smallpox vaccines from immunogenicity and efficacy data from relevant animal models.
Meeting on September 16, 2011, from 8 a.m. to 5:30 p.m.
The public workshop will: (1) Discuss regulatory challenges and approaches related to the licensure of next generation smallpox vaccines; (2) discuss the strengths and weaknesses of various animal models relative to their ability to mimic human disease that can be used to predict the effectiveness of humans; (3) discuss the most appropriate methods to bridge immunogenicity of next-generation smallpox vaccines to licensed smallpox vaccines in clinical trials; and (4) discuss viable methods of extrapolating clinical efficacy of next-generation smallpox vaccines from immunogenicity and efficacy data from relevant animal models.
Thursday, August 4, 2011
Pediatric Advisory Committee
Pediatric Advisory Committee
Meeting on September 23, 2011, from 8 a.m. to 5:30 p.m. (Day 2 of 2)
Agenda: On Friday, September 23, 2011, the Pediatric Advisory Committee will meet to discuss pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act, for Akten (lidocaine hydrochloride), Famvir (famciclovir), Levaquin (levofloxacin), Navstel (balanced salt ophthalmic solution with hypromellose, dextrose, and glutathione), Retrovir (zidovudine), Topamax (topiramate), Triesence (triamcinolone acetonide injectable suspension), Videx EC (didanosine), Ziagen (abacavir sulfate), and Zomig Nasal Spray (zolmitriptan). There will be an informational update on Kaletra (lopinavir/ritonavir) oral solution and tablets.
Meeting on September 23, 2011, from 8 a.m. to 5:30 p.m. (Day 2 of 2)
Agenda: On Friday, September 23, 2011, the Pediatric Advisory Committee will meet to discuss pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act, for Akten (lidocaine hydrochloride), Famvir (famciclovir), Levaquin (levofloxacin), Navstel (balanced salt ophthalmic solution with hypromellose, dextrose, and glutathione), Retrovir (zidovudine), Topamax (topiramate), Triesence (triamcinolone acetonide injectable suspension), Videx EC (didanosine), Ziagen (abacavir sulfate), and Zomig Nasal Spray (zolmitriptan). There will be an informational update on Kaletra (lopinavir/ritonavir) oral solution and tablets.
Pediatric Advisory Committee
Pediatric Advisory Committee
Meeting on September 22, 2011, from 2 p.m. to 6:30 p.m (Day 1 of 2)
Agenda: On Thursday, September 22, 2011, the Pediatric Advisory Committee will meet to discuss pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act (Pub. L. 107-109) and the Pediatric Research Equity Act (Pub. L. 108-155), for Fluarix (influenza virus vaccine), Afluria (influenza virus vaccine), and Abilify (aripiprazole). There will also be an update on a study jointly funded by the Agency for Healthcare Research and Quality (AHRQ) and FDA on antipsychotic use and metabolic effects in children.
Meeting on September 22, 2011, from 2 p.m. to 6:30 p.m (Day 1 of 2)
Agenda: On Thursday, September 22, 2011, the Pediatric Advisory Committee will meet to discuss pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act (Pub. L. 107-109) and the Pediatric Research Equity Act (Pub. L. 108-155), for Fluarix (influenza virus vaccine), Afluria (influenza virus vaccine), and Abilify (aripiprazole). There will also be an update on a study jointly funded by the Agency for Healthcare Research and Quality (AHRQ) and FDA on antipsychotic use and metabolic effects in children.
Tuesday, July 26, 2011
Peripheral and Central Nervous System Drugs Advisory Committee
Peripheral and Central Nervous System Drugs Advisory Committee
Meeting on October 17, 2011, from 8 a.m. to 5 p.m.
Agenda: On October 17, 2011, the committee will discuss supplemental new drug application (sNDA) 21641 (013) for AZILECT (rasagiline mesylate) Tablets, manufactured by Teva Neuroscience, Inc., for the following proposed indication: Treatment of patients with idiopathic (of unknown cause) Parkinson’s disease to slow clinical progression and treat the signs and symptoms of Parkinson’s disease as initial monotherapy (the single drug used to treat) and as adjunct (additional) therapy to levodopa.
Meeting on October 17, 2011, from 8 a.m. to 5 p.m.
Agenda: On October 17, 2011, the committee will discuss supplemental new drug application (sNDA) 21641 (013) for AZILECT (rasagiline mesylate) Tablets, manufactured by Teva Neuroscience, Inc., for the following proposed indication: Treatment of patients with idiopathic (of unknown cause) Parkinson’s disease to slow clinical progression and treat the signs and symptoms of Parkinson’s disease as initial monotherapy (the single drug used to treat) and as adjunct (additional) therapy to levodopa.
Oncologic Drugs Advisory Committee
Oncologic Drugs Advisory Committee
Meeting on September 14, 2011, from 8 a.m. to 5 p.m.
Agenda: On September 14, 2011, during the morning session, the committee will discuss new drug application 021825, with the proposed trade name Ferriprox (deferiprone) filmcoated tablets, application submitted by ApoPharma, Inc., represented by Cato Research Ltd. (authorized U.S. agent). The proposed indication (use) for this product is for the treatment of patients with transfusional iron overload (excess iron in the body related to blood transfusions), when current chelation therapy is inadequate. (Chelation therapy in these patients binds iron in a form that allows it to be eliminated from the body).
During the afternoon session, the committee will consider the development of products for the treatment of patients with nonmetastatic castration resistant prostate cancer (CRPC) who have a rising serum level of prostate-specific antigen (PSA) despite being on androgen deprivation therapy (ADT). There are no products currently approved for this indication. No specific products will be presented or discussed; rather, the committee will be asked to consider possible trial designs and suitable clinical endpoints to establish efficacy that would support a labeled indication for treatment of nonmetastatic CRPC after PSA progression on ADT. Because ADT is an unproven therapy for this condition with serious long-term toxicity, the committee will be asked whether approval of a new therapy in conjunction with continued ADT would be appropriate for patients with non-metastatic CRPC.
Meeting on September 14, 2011, from 8 a.m. to 5 p.m.
Agenda: On September 14, 2011, during the morning session, the committee will discuss new drug application 021825, with the proposed trade name Ferriprox (deferiprone) filmcoated tablets, application submitted by ApoPharma, Inc., represented by Cato Research Ltd. (authorized U.S. agent). The proposed indication (use) for this product is for the treatment of patients with transfusional iron overload (excess iron in the body related to blood transfusions), when current chelation therapy is inadequate. (Chelation therapy in these patients binds iron in a form that allows it to be eliminated from the body).
During the afternoon session, the committee will consider the development of products for the treatment of patients with nonmetastatic castration resistant prostate cancer (CRPC) who have a rising serum level of prostate-specific antigen (PSA) despite being on androgen deprivation therapy (ADT). There are no products currently approved for this indication. No specific products will be presented or discussed; rather, the committee will be asked to consider possible trial designs and suitable clinical endpoints to establish efficacy that would support a labeled indication for treatment of nonmetastatic CRPC after PSA progression on ADT. Because ADT is an unproven therapy for this condition with serious long-term toxicity, the committee will be asked whether approval of a new therapy in conjunction with continued ADT would be appropriate for patients with non-metastatic CRPC.
Friday, July 22, 2011
Vaccines and Related Biological Products Advisory Committee
Vaccines and Related Biological Products Advisory Committee
Meeting on September 20, 2011 8:00 a.m. and 5:15 p.m.
Agenda: On September 20, 2011, the committee will meet in open session to hear an overview of the research program in the Laboratory of Enteric and Sexually Transmitted Diseases, Division of Bacterial, Parasitic and Allergenic Products, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, FDA. The committee will then discuss and make recommendations on the safety and immunogenicity (surrogate endpoint) of Pneumococcal 13-valent conjugate vaccine (Diphtheria CRM197 Protein) in adults aged 50 years and older using an accelerated approval regulatory pathway.
Meeting on September 20, 2011 8:00 a.m. and 5:15 p.m.
Agenda: On September 20, 2011, the committee will meet in open session to hear an overview of the research program in the Laboratory of Enteric and Sexually Transmitted Diseases, Division of Bacterial, Parasitic and Allergenic Products, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, FDA. The committee will then discuss and make recommendations on the safety and immunogenicity (surrogate endpoint) of Pneumococcal 13-valent conjugate vaccine (Diphtheria CRM197 Protein) in adults aged 50 years and older using an accelerated approval regulatory pathway.
Thursday, July 21, 2011
Science Board to the Food and Drug Administration
Science Board to the Food and Drug Administration
Meeting on August 19, 2011, from 9 a.m. to 3 p.m.
Agenda: On August 19, 2011, the Science Board will discuss the FDA’s draft Strategic Plan for Regulatory Science. The Board will be provided with an update on the FDA’s Medical Countermeasures Initiative program plans. The Board will also initiate the charges to the subcommittees for: (1) A science review of the Center for Devices and Radiological Health, and (2) a Medical and Biological Engineering review
Meeting on August 19, 2011, from 9 a.m. to 3 p.m.
Agenda: On August 19, 2011, the Science Board will discuss the FDA’s draft Strategic Plan for Regulatory Science. The Board will be provided with an update on the FDA’s Medical Countermeasures Initiative program plans. The Board will also initiate the charges to the subcommittees for: (1) A science review of the Center for Devices and Radiological Health, and (2) a Medical and Biological Engineering review
Tuesday, July 19, 2011
Arthritis Advisory Committee
Arthritis Advisory Committee
Meeting on September 13, 2011, from 8 a.m. to 5:30 p.m.
Agenda: On September 13, 2011, the committee will discuss the anti-nerve growth factor (Anti-NGF) drug class that is currently under development and the safety issues possibly related to these drugs. These drugs are being developed for the treatment of a variety of chronic painful conditions including osteoarthritis, chronic lower back pain, diabetic peripheral neuropathy, postherpetic neuralgia, chronic pancreatitis, endometriosis, interstitial cystitis, vertebral fracture, thermal injury, and cancer pain. The committee will be asked to determine whether reports of joint destruction represent a safety signal related to the Anti-NGF class of drugs, and whether the risk benefit balance for these drugs favors continued development of the drugs as analgesics
Meeting on September 13, 2011, from 8 a.m. to 5:30 p.m.
Agenda: On September 13, 2011, the committee will discuss the anti-nerve growth factor (Anti-NGF) drug class that is currently under development and the safety issues possibly related to these drugs. These drugs are being developed for the treatment of a variety of chronic painful conditions including osteoarthritis, chronic lower back pain, diabetic peripheral neuropathy, postherpetic neuralgia, chronic pancreatitis, endometriosis, interstitial cystitis, vertebral fracture, thermal injury, and cancer pain. The committee will be asked to determine whether reports of joint destruction represent a safety signal related to the Anti-NGF class of drugs, and whether the risk benefit balance for these drugs favors continued development of the drugs as analgesics
Friday, July 15, 2011
Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee
Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee
Meeting on September 9, 2011, from 8 a.m. to 6 p.m. (Day 2 of 2)
Agenda: On September 8 and 9, 2011, the committee will discuss and make recommendations regarding the safety and effectiveness of transvaginal surgical mesh used for repair of pelvic organ prolapse. FDA is convening this meeting to seek expert opinion on the risks and benefits of these devices in light of adverse events, e.g., vaginal erosion leading to pelvic pain and dyspareunia, and available information on clinical benefit. The committee will be asked to provide scientific and clinical input on the Agency’s proposed premarket and postmarket regulatory strategies for these devices, including reclassification into Class III (premarket approval), labeling improvements and postmarket surveillance studies. The committee will also consider surgical mesh used to treat stress urinary incontinence.
Meeting on September 9, 2011, from 8 a.m. to 6 p.m. (Day 2 of 2)
Agenda: On September 8 and 9, 2011, the committee will discuss and make recommendations regarding the safety and effectiveness of transvaginal surgical mesh used for repair of pelvic organ prolapse. FDA is convening this meeting to seek expert opinion on the risks and benefits of these devices in light of adverse events, e.g., vaginal erosion leading to pelvic pain and dyspareunia, and available information on clinical benefit. The committee will be asked to provide scientific and clinical input on the Agency’s proposed premarket and postmarket regulatory strategies for these devices, including reclassification into Class III (premarket approval), labeling improvements and postmarket surveillance studies. The committee will also consider surgical mesh used to treat stress urinary incontinence.
Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee
Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee
Meeting on September 8, 2011, from 8 a.m. to 6 p.m. (Day 1 of 2)
Agenda: On September 8 and 9, 2011, the committee will discuss and make recommendations regarding the safety and effectiveness of transvaginal surgical mesh used for repair of pelvic organ prolapse. FDA is convening this meeting to seek expert opinion on the risks and benefits of these devices in light of adverse events, e.g., vaginal erosion leading to pelvic pain and dyspareunia, and available information on clinical benefit. The committee will be asked to provide scientific and clinical input on the Agency’s proposed premarket and postmarket regulatory strategies for these devices, including reclassification into Class III (premarket approval), labeling improvements and postmarket surveillance studies. The committee will also consider surgical mesh used to treat stress urinary incontinence.
Meeting on September 8, 2011, from 8 a.m. to 6 p.m. (Day 1 of 2)
Agenda: On September 8 and 9, 2011, the committee will discuss and make recommendations regarding the safety and effectiveness of transvaginal surgical mesh used for repair of pelvic organ prolapse. FDA is convening this meeting to seek expert opinion on the risks and benefits of these devices in light of adverse events, e.g., vaginal erosion leading to pelvic pain and dyspareunia, and available information on clinical benefit. The committee will be asked to provide scientific and clinical input on the Agency’s proposed premarket and postmarket regulatory strategies for these devices, including reclassification into Class III (premarket approval), labeling improvements and postmarket surveillance studies. The committee will also consider surgical mesh used to treat stress urinary incontinence.
Monday, July 11, 2011
Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee
Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee Meeting on September 9, 2011, from 8 a.m. to 4:30 p.m
Agenda: On September 9, 2011, the committees will discuss the benefits and risks of long-term bisphosphonate use for the treatment and prevention of osteoporosis (thinning and weakening of bones that increases the chance of having a broken bone) in light of the emergence of the safety concerns of osteonecrosis of the jaw (jawbone death) and atypical femur fractures (unusual broken thigh bone) that may be associated with the long-term use of bisphosphonates. Bisphosphonates for the treatment and prevention of osteoporosis include: FOSAMAX (alendronate sodium) tablets and solution and FOSAMAX PLUS D (alendronate sodium/cholecalciferol) tablets, Merck & Co., Inc.; ACTONEL (risedronate sodium) tablets, ATELVIA (risedronate sodium) delayed release tablets, and ACTONEL WITH CALCIUM (Copackaged) (risedronate sodium with calcium carbonate) tablets, Warner Chilcott, LLC; BONIVA (ibandronate sodium) tablets and injection, Roche Therapeutics, Inc.; RECLAST (zoledronic acid) injection, Novartis Pharmaceuticals Corp.; and the generic equivalents for these products, if any.
Agenda: On September 9, 2011, the committees will discuss the benefits and risks of long-term bisphosphonate use for the treatment and prevention of osteoporosis (thinning and weakening of bones that increases the chance of having a broken bone) in light of the emergence of the safety concerns of osteonecrosis of the jaw (jawbone death) and atypical femur fractures (unusual broken thigh bone) that may be associated with the long-term use of bisphosphonates. Bisphosphonates for the treatment and prevention of osteoporosis include: FOSAMAX (alendronate sodium) tablets and solution and FOSAMAX PLUS D (alendronate sodium/cholecalciferol) tablets, Merck & Co., Inc.; ACTONEL (risedronate sodium) tablets, ATELVIA (risedronate sodium) delayed release tablets, and ACTONEL WITH CALCIUM (Copackaged) (risedronate sodium with calcium carbonate) tablets, Warner Chilcott, LLC; BONIVA (ibandronate sodium) tablets and injection, Roche Therapeutics, Inc.; RECLAST (zoledronic acid) injection, Novartis Pharmaceuticals Corp.; and the generic equivalents for these products, if any.
Friday, July 8, 2011
General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee
General and Plastic Surgery Devices Panel of the Medical Devices Advisory Meeting on August 31st 2011, from 8 a.m. to 6 p.m. (Day 2 of 2)
Agenda: On August 30 and 31, 2011, the committee will discuss and make recommendations on postmarketing issues related to silicone gel-filled breast implants. This meeting is regarding the discussion of different innovative methodological approaches to the conduct of postmarket studies regarding silicone gel breast implants. Additionally, the panel will discuss key long-term safety issues associated with silicone gel breast implants in the real-world setting.
Agenda: On August 30 and 31, 2011, the committee will discuss and make recommendations on postmarketing issues related to silicone gel-filled breast implants. This meeting is regarding the discussion of different innovative methodological approaches to the conduct of postmarket studies regarding silicone gel breast implants. Additionally, the panel will discuss key long-term safety issues associated with silicone gel breast implants in the real-world setting.
General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee
General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee
August 30th 2011, from 8 a.m. to 6 p.m. (Day 1 of 2)
Agenda: On August 30 and 31, 2011, the committee will discuss and make recommendations on postmarketing issues related to silicone gel-filled breast implants. This meeting is regarding the discussion of different innovative methodological approaches to the conduct of postmarket studies regarding silicone gel breast implants. Additionally, the panel will discuss key long-term safety issues associated with silicone gel breast implants in the real-world setting.
August 30th 2011, from 8 a.m. to 6 p.m. (Day 1 of 2)
Agenda: On August 30 and 31, 2011, the committee will discuss and make recommendations on postmarketing issues related to silicone gel-filled breast implants. This meeting is regarding the discussion of different innovative methodological approaches to the conduct of postmarket studies regarding silicone gel breast implants. Additionally, the panel will discuss key long-term safety issues associated with silicone gel breast implants in the real-world setting.
Thursday, July 7, 2011
Blood Products Advisory Committee
Blood Products Advisory Committee
Meeting on August 3, 2011, from 8 a.m. to 2:30 p.m.
Agenda: On August 3, 2011, the committee will discuss measures to preserve the blood supply during a severe emergency. In the afternoon, the committee will hear the following updates: Summary of the June 7–8, 2011, Health and Human Services Advisory Committee on Blood Safety and Availability meeting; summary of the May 17–18, 2011, public workshop on risk mitigation strategies to address procoagulant activity in immune globulin products; and summary of the August 1–2, 2011, Transmissible Spongiform Encephalopathies Advisory Committee meeting.
Meeting on August 3, 2011, from 8 a.m. to 2:30 p.m.
Agenda: On August 3, 2011, the committee will discuss measures to preserve the blood supply during a severe emergency. In the afternoon, the committee will hear the following updates: Summary of the June 7–8, 2011, Health and Human Services Advisory Committee on Blood Safety and Availability meeting; summary of the May 17–18, 2011, public workshop on risk mitigation strategies to address procoagulant activity in immune globulin products; and summary of the August 1–2, 2011, Transmissible Spongiform Encephalopathies Advisory Committee meeting.
Blood Products Advisory Committee
Blood Products Advisory Committee
Meeting on August 2, 2011, from 1:30 p.m. to 5 p.m.
Agenda: On August 2, 2011, the committee will discuss a study on the incidence of Trypanosoma cruzi infection in blood donors and its implications for selective testing of blood donors.
Meeting on August 2, 2011, from 1:30 p.m. to 5 p.m.
Agenda: On August 2, 2011, the committee will discuss a study on the incidence of Trypanosoma cruzi infection in blood donors and its implications for selective testing of blood donors.
Wednesday, July 6, 2011
Cardiovascular and Renal Drugs Advisory Committee
Cardiovascular and Renal Drugs Advisory Committee
Meeting on September 8, 2011, from 8 a.m. to 5 p.m.
Agenda: On September 8, 2011, the committee will discuss new drug application (NDA) 202439, rivaroxaban tablets, submitted by Johnson & Johnson Pharmaceutical Research and Development, L.L.C., on behalf of Ortho- McNeil-Janssen-Pharmaceuticals, for the prevention of stroke and systemic embolism (blood clots other than in the head) in patients with nonvalvular atrial fibrillation (abnormally rapid contractions of the atria, the upper chambers of the heart).
Meeting on September 8, 2011, from 8 a.m. to 5 p.m.
Agenda: On September 8, 2011, the committee will discuss new drug application (NDA) 202439, rivaroxaban tablets, submitted by Johnson & Johnson Pharmaceutical Research and Development, L.L.C., on behalf of Ortho- McNeil-Janssen-Pharmaceuticals, for the prevention of stroke and systemic embolism (blood clots other than in the head) in patients with nonvalvular atrial fibrillation (abnormally rapid contractions of the atria, the upper chambers of the heart).
Tuesday, July 5, 2011
Advisory Committee for Pharmaceutical Science and Clinical Pharmacology
Advisory Committee for Pharmaceutical Science and Clinical Pharmacology
July 27, 2011, from 8 a.m. to 5 p.m. (Day 2 of 2)
Agenda: On July 27, 2011, the committee will discuss current strategies for FDA’s Office of Pharmaceutical Science implementation of quality by design principles within its review offices, incorporating an update on the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use Activities. The committee will also receive awareness presentations on FDA’s current partnering with the United States Pharmacopeia, principally to discuss the Monograph Modernization Program.
July 27, 2011, from 8 a.m. to 5 p.m. (Day 2 of 2)
Agenda: On July 27, 2011, the committee will discuss current strategies for FDA’s Office of Pharmaceutical Science implementation of quality by design principles within its review offices, incorporating an update on the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use Activities. The committee will also receive awareness presentations on FDA’s current partnering with the United States Pharmacopeia, principally to discuss the Monograph Modernization Program.
Advisory Committee for Pharmaceutical Science and Clinical Pharmacology
Advisory Committee for Pharmaceutical Science and Clinical Pharmacology
July 26, 2011, from 8 a.m. to 5:30 p.m. (Day 1 of 2)
Agenda: On July 26, 2011, the committee will discuss presentations by the Office of Generic Drugs (OGD) on bioequivalence issues and quality standards relative to narrow therapeutic index (NTI) drug products as a class. In response to feedback during the April 13, 2010, Advisory Committee for Pharmaceutical Science and Clinical Pharmacology (ACPS–CP) meeting, the committee will further discuss the definition and list of NTI drugs, as well as proposed bioequivalence standards for these products. The committee will also receive awareness presentations relevant to OGD’s ongoing focus on quality and safety of generic drug products. Presentations will outline current activities seeking to better understand the impact of formulation and quality on the performance of generic drug products and current thinking related to potential regulatory pathways for these issues.
July 26, 2011, from 8 a.m. to 5:30 p.m. (Day 1 of 2)
Agenda: On July 26, 2011, the committee will discuss presentations by the Office of Generic Drugs (OGD) on bioequivalence issues and quality standards relative to narrow therapeutic index (NTI) drug products as a class. In response to feedback during the April 13, 2010, Advisory Committee for Pharmaceutical Science and Clinical Pharmacology (ACPS–CP) meeting, the committee will further discuss the definition and list of NTI drugs, as well as proposed bioequivalence standards for these products. The committee will also receive awareness presentations relevant to OGD’s ongoing focus on quality and safety of generic drug products. Presentations will outline current activities seeking to better understand the impact of formulation and quality on the performance of generic drug products and current thinking related to potential regulatory pathways for these issues.
Monday, June 27, 2011
Scientific Evaluation of Modified Risk Tobacco Product Applications
Scientific Evaluation of Modified Risk Tobacco Product Applications
Meeting on August 26, 2011, from 8:30 a.m. to 4:00 p.m. (Day 2 of 2)
Agenda: The purpose of the public workshop is to create a forum for appropriate scientific and medical experts and other interested stakeholders to provide input on these topics. FDA will take the information it obtains from the public workshop into account as it determines how best to implement the MRTPs provisions of the Tobacco Control Act. FDA is also opening a public docket to receive comments on these topics.
Meeting on August 26, 2011, from 8:30 a.m. to 4:00 p.m. (Day 2 of 2)
Agenda: The purpose of the public workshop is to create a forum for appropriate scientific and medical experts and other interested stakeholders to provide input on these topics. FDA will take the information it obtains from the public workshop into account as it determines how best to implement the MRTPs provisions of the Tobacco Control Act. FDA is also opening a public docket to receive comments on these topics.
Scientific Evaluation of Modified Risk Tobacco Product Applications
Scientific Evaluation of Modified Risk Tobacco Product Applications
Meeting on August 25, 2011, from 8:30 a.m. to 5:30 p.m. (Day 1 of 2)
Agenda: The purpose of the public workshop is to create a forum for appropriate scientific and medical experts and other interested stakeholders to provide input on these topics. FDA will take the information it obtains from the public workshop into account as it determines how best to implement the MRTPs provisions of the Tobacco Control Act. FDA is also opening a public docket to receive comments on these topics.
Meeting on August 25, 2011, from 8:30 a.m. to 5:30 p.m. (Day 1 of 2)
Agenda: The purpose of the public workshop is to create a forum for appropriate scientific and medical experts and other interested stakeholders to provide input on these topics. FDA will take the information it obtains from the public workshop into account as it determines how best to implement the MRTPs provisions of the Tobacco Control Act. FDA is also opening a public docket to receive comments on these topics.
Circulatory System Devices Panel of the Medical Devices Advisory Committee
Circulatory System Devices Panel of the Medical Devices Advisory Committee
Meeting on July 20 and 21, 2011, from 8 a.m. to 6 p.m
Agenda: On July 20, 2011, the committee will discuss, make recommendations, and vote on information related to the premarket approval application for the Edwards SAPIEN Transcatheter Heart Valve sponsored by Edwards Lifesciences. The Edwards SAPIENTM Transcatheter Heart Valve, model 9000TFX, sizes 23 millimeters (mm) and 26 mm and accessories implant system consists of the following: The Edwards SAPIEN Transcatheter Heart Valve consists of a heterologous (bovine) pericardium leaflet valve sutured within a stainless steel mesh frame, with a polyester skirt. It is offered in 2 sizes, a 23 mm and a 26 mm. The RetroFlex 3 Delivery System is used to advance the bioprosthesis through the RetroFlex sheath over a guidewire and to track the bioprosthesis over the aortic arch and for crossing and positioning in the native valve. The delivery system also comes with a sheath, introducer, loader, dilator, balloon (used to pre-dilate the native annulus) and a crimper
Agenda: On July 21, 2011, the committee will discuss, make recommendations, and vote on information related to the humanitarian device exemption for the Berlin Heart EXCOR Pediatric Ventricular Assist Device (VAD) sponsored by Berlin Heart, Inc. The Berlin Heart EXCOR Pediatric VAD device is a pneumatically-driven extracorporeal ventricular assist device. It is designed to provide bridge-to transplant mechanical support to the heart. The system consists of one or two extracorporeal blood pumps (univentricular or biventricular support), cannulae for the connection of the blood pumps to the atria and great arteries, and the IKUS Stationary Driving Unit (electro-pneumatic driving system).
Meeting on July 20 and 21, 2011, from 8 a.m. to 6 p.m
Agenda: On July 20, 2011, the committee will discuss, make recommendations, and vote on information related to the premarket approval application for the Edwards SAPIEN Transcatheter Heart Valve sponsored by Edwards Lifesciences. The Edwards SAPIENTM Transcatheter Heart Valve, model 9000TFX, sizes 23 millimeters (mm) and 26 mm and accessories implant system consists of the following: The Edwards SAPIEN Transcatheter Heart Valve consists of a heterologous (bovine) pericardium leaflet valve sutured within a stainless steel mesh frame, with a polyester skirt. It is offered in 2 sizes, a 23 mm and a 26 mm. The RetroFlex 3 Delivery System is used to advance the bioprosthesis through the RetroFlex sheath over a guidewire and to track the bioprosthesis over the aortic arch and for crossing and positioning in the native valve. The delivery system also comes with a sheath, introducer, loader, dilator, balloon (used to pre-dilate the native annulus) and a crimper
Agenda: On July 21, 2011, the committee will discuss, make recommendations, and vote on information related to the humanitarian device exemption for the Berlin Heart EXCOR Pediatric Ventricular Assist Device (VAD) sponsored by Berlin Heart, Inc. The Berlin Heart EXCOR Pediatric VAD device is a pneumatically-driven extracorporeal ventricular assist device. It is designed to provide bridge-to transplant mechanical support to the heart. The system consists of one or two extracorporeal blood pumps (univentricular or biventricular support), cannulae for the connection of the blood pumps to the atria and great arteries, and the IKUS Stationary Driving Unit (electro-pneumatic driving system).
Circulatory System Devices Panel of the Medical Devices Advisory Committee
Circulatory System Devices Panel of the Medical Devices Advisory Committee
Meeting on July 21, 2011, from 8 a.m. to 6 p.m (Day 2 of 2)
Agenda: On July 21, 2011, the committee will discuss, make recommendations, and vote on information related to the humanitarian device exemption for the Berlin Heart EXCOR Pediatric Ventricular Assist Device (VAD) sponsored by Berlin Heart, Inc. The Berlin Heart EXCOR Pediatric VAD device is a pneumatically-driven extracorporeal ventricular assist device. It is designed to provide bridge-to transplant mechanical support to the heart. The system consists of one or two extracorporeal blood pumps (univentricular or biventricular support), cannulae for the connection of the blood pumps to the atria and great arteries, and the IKUS Stationary Driving Unit (electro-pneumatic driving system).
Meeting on July 21, 2011, from 8 a.m. to 6 p.m (Day 2 of 2)
Agenda: On July 21, 2011, the committee will discuss, make recommendations, and vote on information related to the humanitarian device exemption for the Berlin Heart EXCOR Pediatric Ventricular Assist Device (VAD) sponsored by Berlin Heart, Inc. The Berlin Heart EXCOR Pediatric VAD device is a pneumatically-driven extracorporeal ventricular assist device. It is designed to provide bridge-to transplant mechanical support to the heart. The system consists of one or two extracorporeal blood pumps (univentricular or biventricular support), cannulae for the connection of the blood pumps to the atria and great arteries, and the IKUS Stationary Driving Unit (electro-pneumatic driving system).
Circulatory System Devices Panel of the Medical Devices Advisory Committee
Circulatory System Devices Panel of the Medical Devices Advisory Committee
Meeting on July 20, 2011, from 8 a.m. to 6 p.m (Day 1 of 2)]
Agenda: On July 20, 2011, the committee will discuss, make recommendations, and vote on information related to the premarket approval application for the Edwards SAPIEN Transcatheter Heart Valve sponsored by Edwards Lifesciences. The Edwards SAPIENTM Transcatheter Heart Valve, model 9000TFX, sizes 23 millimeters (mm) and 26 mm and accessories implant system consists of the following: The Edwards SAPIEN Transcatheter Heart Valve consists of a heterologous (bovine) pericardium leaflet valve sutured within a stainless steel mesh frame, with a polyester skirt. It is offered in 2 sizes, a 23 mm and a 26 mm. The RetroFlex 3 Delivery System is used to advance the bioprosthesis through the RetroFlex sheath over a guidewire and to track the bioprosthesis over the aortic arch and for crossing and positioning in the native valve. The delivery system also comes with a sheath, introducer, loader, dilator, balloon (used to pre-dilate the native annulus) and a crimper
Meeting on July 20, 2011, from 8 a.m. to 6 p.m (Day 1 of 2)]
Agenda: On July 20, 2011, the committee will discuss, make recommendations, and vote on information related to the premarket approval application for the Edwards SAPIEN Transcatheter Heart Valve sponsored by Edwards Lifesciences. The Edwards SAPIENTM Transcatheter Heart Valve, model 9000TFX, sizes 23 millimeters (mm) and 26 mm and accessories implant system consists of the following: The Edwards SAPIEN Transcatheter Heart Valve consists of a heterologous (bovine) pericardium leaflet valve sutured within a stainless steel mesh frame, with a polyester skirt. It is offered in 2 sizes, a 23 mm and a 26 mm. The RetroFlex 3 Delivery System is used to advance the bioprosthesis through the RetroFlex sheath over a guidewire and to track the bioprosthesis over the aortic arch and for crossing and positioning in the native valve. The delivery system also comes with a sheath, introducer, loader, dilator, balloon (used to pre-dilate the native annulus) and a crimper
Wednesday, June 22, 2011
Oncologic Drugs Advisory Committee
Oncologic Drugs Advisory Committee
Meeting on July 14, 2011, from 8 a.m. to 5 p.m.
Agenda: On July 14, 2011, during the morning session, the committee will discuss biologics license application (BLA) 125388, with the proposed trade name ADCETRIS (brentuximab vedotin) for injection, submitted by Seattle Genetics, Inc. The proposed indication (use) for this product is for the treatment of relapsed or refractory (resistant to previous standard treatments) Hodgkin’s lymphoma. During the afternoon session, the committee will discuss BLA 125399, with the proposed trade name ADCETRIS (brentuximab vedotin) for injection, submitted by Seattle Genetics, Inc. The proposed indication (use) for this product is for the treatment of relapsed or refractory systemic anaplastic large cell lymphoma.
Meeting on July 14, 2011, from 8 a.m. to 5 p.m.
Agenda: On July 14, 2011, during the morning session, the committee will discuss biologics license application (BLA) 125388, with the proposed trade name ADCETRIS (brentuximab vedotin) for injection, submitted by Seattle Genetics, Inc. The proposed indication (use) for this product is for the treatment of relapsed or refractory (resistant to previous standard treatments) Hodgkin’s lymphoma. During the afternoon session, the committee will discuss BLA 125399, with the proposed trade name ADCETRIS (brentuximab vedotin) for injection, submitted by Seattle Genetics, Inc. The proposed indication (use) for this product is for the treatment of relapsed or refractory systemic anaplastic large cell lymphoma.
Monday, June 13, 2011
Endocrinologic and Metabolic Drugs Advisory Committee Meeting Announcement
Endocrinologic and Metabolic Drugs Advisory Committee Meeting Announcement
Committee Meeting on July 19, 2011, from 8 a.m. to 5 p.m.
Agenda: On July 19, 2011, the committee will discuss new drug application (NDA) 202293 dapagliflozin, manufactured by Bristol-Myers Squibb and AstraZeneca. Dapagliflozin is the first drug in the class of sodium-glucose co-transporter 2 (SGLT2) inhibitors, developed as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Committee Meeting on July 19, 2011, from 8 a.m. to 5 p.m.
Agenda: On July 19, 2011, the committee will discuss new drug application (NDA) 202293 dapagliflozin, manufactured by Bristol-Myers Squibb and AstraZeneca. Dapagliflozin is the first drug in the class of sodium-glucose co-transporter 2 (SGLT2) inhibitors, developed as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Tuesday, June 7, 2011
Tobacco Products Scientific Advisory Committee
Tobacco Products Scientific Advisory Committee
Committee Meeting on July 21, 2011, from 9 a.m. to 5 p.m. and July 22, 2011, from 8 a.m. to 5 p.m.
Agenda: On the morning of July 21, 2011, the committee will discuss changes proposed by committee members to the Tobacco Products Scientific Advisory Committee (TPSAC) Menthol Report submitted to the Agency on March 18, 2011. The committee will consider additional oral and written comments from the public on the Menthol Report and the proposed changes to the report, as submitted according to the instructions in the Procedure portion of this document. The committee will consider and deliberate on proposed changes to the report and adopt amendments that constitute the advice of the committee. Redacted versions of the document, reflecting the changes to the report proposed by the committee members, will be made available on the FDA Web site at http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/TobaccoProductsScientificAdvisoryCommittee/ucm237359.htm, no later than June 22, 2011. On the afternoon of July 21, 2011, and on July 22, 2011, the TPSAC will initiate discussions on the issue of the nature and impact of the use of dissolvable tobacco products on the public health. These discussions will begin the process for the TPSAC’s required report to the Secretary of Health and Human Services regarding the issue of the nature and impact of the use of dissolvable tobacco products on the public health, including such use among children. The final report should take into consideration the following: (1) The risks and benefits to the population as a whole, including users and nonusers of tobacco products; (2) the increased or decreased likelihood that existing users of tobacco products will stop using such products; and (3) the increased or decreased likelihood that those who do not use tobacco products will start using such products.
Committee Meeting on July 21, 2011, from 9 a.m. to 5 p.m. and July 22, 2011, from 8 a.m. to 5 p.m.
Agenda: On the morning of July 21, 2011, the committee will discuss changes proposed by committee members to the Tobacco Products Scientific Advisory Committee (TPSAC) Menthol Report submitted to the Agency on March 18, 2011. The committee will consider additional oral and written comments from the public on the Menthol Report and the proposed changes to the report, as submitted according to the instructions in the Procedure portion of this document. The committee will consider and deliberate on proposed changes to the report and adopt amendments that constitute the advice of the committee. Redacted versions of the document, reflecting the changes to the report proposed by the committee members, will be made available on the FDA Web site at http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/TobaccoProductsScientificAdvisoryCommittee/ucm237359.htm, no later than June 22, 2011. On the afternoon of July 21, 2011, and on July 22, 2011, the TPSAC will initiate discussions on the issue of the nature and impact of the use of dissolvable tobacco products on the public health. These discussions will begin the process for the TPSAC’s required report to the Secretary of Health and Human Services regarding the issue of the nature and impact of the use of dissolvable tobacco products on the public health, including such use among children. The final report should take into consideration the following: (1) The risks and benefits to the population as a whole, including users and nonusers of tobacco products; (2) the increased or decreased likelihood that existing users of tobacco products will stop using such products; and (3) the increased or decreased likelihood that those who do not use tobacco products will start using such products.
Gastrointestinal Drugs Advisory Committee
Gastrointestinal Drugs Advisory Committee
Committee Meeting on July 21, 2011, from 8 a.m. to 4 p.m.
Agenda: On July 21, 2011, the committee will discuss the results from a clinical trial of supplement biologics license application 103772/5301, REMICADE (infliximab), by Centocor Ortho Biotech Inc., in the treatment of pediatric patients with moderately to severely active ulcerative colitis.
Committee Meeting on July 21, 2011, from 8 a.m. to 4 p.m.
Agenda: On July 21, 2011, the committee will discuss the results from a clinical trial of supplement biologics license application 103772/5301, REMICADE (infliximab), by Centocor Ortho Biotech Inc., in the treatment of pediatric patients with moderately to severely active ulcerative colitis.
Tuesday, May 24, 2011
Cellular, Tissue and Gene Therapies Advisory Committee
Cellular, Tissue and Gene Therapies Advisory Committee
Committee Meeting on June 29, 2011, from 8 a.m. to 5 p.m.
Agenda: On June 29, 2011, the committee will discuss cellular and gene therapy products for the treatment of retinal disorders. Topics to be considered include the following: (1) Efficacy endpoints in pediatric and adult populations, (2) potential safety issues related to repeat administration or second eye administration, and (3) evaluation of product delivery into target site.
Committee Meeting on June 29, 2011, from 8 a.m. to 5 p.m.
Agenda: On June 29, 2011, the committee will discuss cellular and gene therapy products for the treatment of retinal disorders. Topics to be considered include the following: (1) Efficacy endpoints in pediatric and adult populations, (2) potential safety issues related to repeat administration or second eye administration, and (3) evaluation of product delivery into target site.
Microbiology Devices Panel of the Medical Devices Advisory Committee
Microbiology Devices Panel of the Medical Devices Advisory Committee
Committee Meeting on June 29, 2011, from 8 a.m. to 6 p.m.
Agenda: On June 29, 2011, the committee will discuss and make recommendations regarding the possible reclassification of molecular diagnostics for the rapid detection of Mycobacterium tuberculosis complex and the detection of genetic mutations which confer antibiotic resistance in M. tuberculosis complex. Discussion would include the appropriate information and acceptable performance characteristics that would be required to assess the safety and effectiveness of rapid diagnostic tests for M. tuberculosis complex, and whether these can be sufficiently specified to support possible reclassification.
Committee Meeting on June 29, 2011, from 8 a.m. to 6 p.m.
Agenda: On June 29, 2011, the committee will discuss and make recommendations regarding the possible reclassification of molecular diagnostics for the rapid detection of Mycobacterium tuberculosis complex and the detection of genetic mutations which confer antibiotic resistance in M. tuberculosis complex. Discussion would include the appropriate information and acceptable performance characteristics that would be required to assess the safety and effectiveness of rapid diagnostic tests for M. tuberculosis complex, and whether these can be sufficiently specified to support possible reclassification.
Proposal To Withdraw Approval for the Breast Cancer Indication for Bevacizumab; Hearing
Proposal To Withdraw Approval for the Breast Cancer Indication for Bevacizumab; Hearing
Committee Meeting on June 28 and 29, 2011, from 8 a.m. to 5 p.m.
Agenda: The Food and Drug Administration (FDA) is granting a hearing to Genentech, Inc. (Genentech), on the Center for Drug Evaluation and Research''s (CDER''s) proposal to withdraw approval of the breast cancer indication for bevacizumab (Avastin). Genentech is the sponsor for Avastin. Genentech and CDER are the parties to the hearing. The issues to be discussed and resolved at the hearing relate directly to the statutory and regulatory standard for FDA to withdraw accelerated approval of the metastatic breast cancer (MBC or breast cancer) indication for Avastin.
Committee Meeting on June 28 and 29, 2011, from 8 a.m. to 5 p.m.
Agenda: The Food and Drug Administration (FDA) is granting a hearing to Genentech, Inc. (Genentech), on the Center for Drug Evaluation and Research''s (CDER''s) proposal to withdraw approval of the breast cancer indication for bevacizumab (Avastin). Genentech is the sponsor for Avastin. Genentech and CDER are the parties to the hearing. The issues to be discussed and resolved at the hearing relate directly to the statutory and regulatory standard for FDA to withdraw accelerated approval of the metastatic breast cancer (MBC or breast cancer) indication for Avastin.
Pulmonary-Allergy Drugs Advisory Committee
Pulmonary-Allergy Drugs Advisory Committee
Committee Meeting on June 23, 2011, from 8:30 a.m. to 5 p.m.
Agenda: On June 23, 2011, the committee will discuss the new drug application (NDA) 22150, icatibant solution for injection (proposed trade name Firazyr), Shire Human Genetic Therapies, for the proposed indication of treatment of acute attacks of hereditary angioedema.
Committee Meeting on June 23, 2011, from 8:30 a.m. to 5 p.m.
Agenda: On June 23, 2011, the committee will discuss the new drug application (NDA) 22150, icatibant solution for injection (proposed trade name Firazyr), Shire Human Genetic Therapies, for the proposed indication of treatment of acute attacks of hereditary angioedema.
Arthritis Advisory Committee
Arthritis Advisory Committee
Committee Meeting on June 21, 2011, from 8:30 a.m. to 4 p.m.
Agenda: On June 21, 2011, the committee will discuss the supplemental biologics license application 125319, ILARIS (canakinumab), Novartis Pharmaceuticals Corp., for the following proposed indication: ‘‘ILARIS is indicated for the treatment of gouty arthritis attacks. ILARIS has also been shown to extend the time to the next attack and reduce the frequency of subsequent attacks.’’
Committee Meeting on June 21, 2011, from 8:30 a.m. to 4 p.m.
Agenda: On June 21, 2011, the committee will discuss the supplemental biologics license application 125319, ILARIS (canakinumab), Novartis Pharmaceuticals Corp., for the following proposed indication: ‘‘ILARIS is indicated for the treatment of gouty arthritis attacks. ILARIS has also been shown to extend the time to the next attack and reduce the frequency of subsequent attacks.’’
Dermatologic and Ophthalmic Drugs Advisory Committee
Dermatologic and Ophthalmic Drugs Advisory Committee
Committee Meeting on June 17, 2011, from 8 a.m. to 4:30 p.m.
Agenda: On June 17, 2011, the committee will discuss biologics license application (BLA) 125387, aflibercept ophthalmic solution, proposed trade name EYLEA, sponsored by Regeneron Pharmaceuticals, Inc., indicated for the treatment of neovascular age-related macular degeneration (wet AMD)
Committee Meeting on June 17, 2011, from 8 a.m. to 4:30 p.m.
Agenda: On June 17, 2011, the committee will discuss biologics license application (BLA) 125387, aflibercept ophthalmic solution, proposed trade name EYLEA, sponsored by Regeneron Pharmaceuticals, Inc., indicated for the treatment of neovascular age-related macular degeneration (wet AMD)
Tuesday, March 22, 2011
Microbiology Devices Panel of the Medical Devices Advisory Committee
Microbiology Devices Panel of the Medical Devices Advisory Committee
Committee Meeting on June 29, 2011, from 8 a.m. to 6 p.m.
Agenda: On June 29, 2011, the committee will discuss and make recommendations regarding the possible reclassification of molecular diagnostics for the rapid detection of Mycobacterium tuberculosis complex and the detection of genetic mutations which confer antibiotic resistance in M. tuberculosis complex. Discussion would include the appropriate information and acceptable performance characteristics that would be required to assess the safety and effectiveness of rapid diagnostic tests for M. tuberculosis complex, and whether these can be sufficiently specified to support possible reclassification.
Committee Meeting on June 29, 2011, from 8 a.m. to 6 p.m.
Agenda: On June 29, 2011, the committee will discuss and make recommendations regarding the possible reclassification of molecular diagnostics for the rapid detection of Mycobacterium tuberculosis complex and the detection of genetic mutations which confer antibiotic resistance in M. tuberculosis complex. Discussion would include the appropriate information and acceptable performance characteristics that would be required to assess the safety and effectiveness of rapid diagnostic tests for M. tuberculosis complex, and whether these can be sufficiently specified to support possible reclassification.
Joint Meeting of the Nonprescription Drugs Advisory Committee and the Pediatric Advisory Committee
Joint Meeting of the Nonprescription Drugs Advisory Committee and the Pediatric Advisory Committee
Committee Meeting on May 18, 2011, from 8 a.m. to 12:00 p.m.
Agenda: On May 17 and 18, 2011, the committees will review pertinent pharmacokinetic (how drugs are absorbed, distributed, used, and eliminated by the body), safety and efficacy data, and discuss whether new dosing information for oral over-the-counter (OTC) drug products containing acetaminophen should be added to the label for children less than 2 years of age. In addition, the committees will consider adding a weight-based dosing regimen to the existing age-based dosing regimen for children 2 to 12 years of age. Dosing for children 12 years of age and older will not be discussed. Lastly, the committees will discuss ways that administration by caregivers can be improved so that medication errors can be minimized.
Committee Meeting on May 18, 2011, from 8 a.m. to 12:00 p.m.
Agenda: On May 17 and 18, 2011, the committees will review pertinent pharmacokinetic (how drugs are absorbed, distributed, used, and eliminated by the body), safety and efficacy data, and discuss whether new dosing information for oral over-the-counter (OTC) drug products containing acetaminophen should be added to the label for children less than 2 years of age. In addition, the committees will consider adding a weight-based dosing regimen to the existing age-based dosing regimen for children 2 to 12 years of age. Dosing for children 12 years of age and older will not be discussed. Lastly, the committees will discuss ways that administration by caregivers can be improved so that medication errors can be minimized.
Joint Meeting of the Nonprescription Drugs Advisory Committee and the Pediatric Advisory Committee
Joint Meeting of the Nonprescription Drugs Advisory Committee and the Pediatric Advisory Committee
Committee Meeting on May 17, 2011, from 8 a.m. to 5:00 p.m.
Agenda: On May 17 and 18, 2011, the committees will review pertinent pharmacokinetic (how drugs are absorbed, distributed, used, and eliminated by the body), safety and efficacy data, and discuss whether new dosing information for oral over-the-counter (OTC) drug products containing acetaminophen should be added to the label for children less than 2 years of age. In addition, the committees will consider adding a weight-based dosing regimen to the existing age-based dosing regimen for children 2 to 12 years of age. Dosing for children 12 years of age and older will not be discussed. Lastly, the committees will discuss ways that administration by caregivers can be improved so that medication errors can be minimized.
Committee Meeting on May 17, 2011, from 8 a.m. to 5:00 p.m.
Agenda: On May 17 and 18, 2011, the committees will review pertinent pharmacokinetic (how drugs are absorbed, distributed, used, and eliminated by the body), safety and efficacy data, and discuss whether new dosing information for oral over-the-counter (OTC) drug products containing acetaminophen should be added to the label for children less than 2 years of age. In addition, the committees will consider adding a weight-based dosing regimen to the existing age-based dosing regimen for children 2 to 12 years of age. Dosing for children 12 years of age and older will not be discussed. Lastly, the committees will discuss ways that administration by caregivers can be improved so that medication errors can be minimized.
Allergenic Products Advisory Committee
Allergenic Products Advisory Committee
Committee Meeting on May 12, 2011, from 8 a.m. to approximately 3:30 p.m.
Agenda: On May 12, 2011, in open session, the committee will receive updates and have discussion on the following topics: (1) Structure and Activities of the Laboratory of Immunobiochemistry (the Laboratory), Division of Bacterial, Parasitic, and Allergenic Products, Center for Biologics Evaluation and Research, FDA; (2) enzyme-linked immunosorbent assay replacement of radial immunodiffusion assays for potency determinations of cat and ragweed pollen allergen extracts by the Laboratory; (3) statistical considerations for the design and interpretation of phase III clinical trials of allergenic products; (4) environmental exposure chambers for phase III studies of allergenic products, and (5) International Organization for Standardization (ISO) 17025 accreditation of the Laboratory.
Committee Meeting on May 12, 2011, from 8 a.m. to approximately 3:30 p.m.
Agenda: On May 12, 2011, in open session, the committee will receive updates and have discussion on the following topics: (1) Structure and Activities of the Laboratory of Immunobiochemistry (the Laboratory), Division of Bacterial, Parasitic, and Allergenic Products, Center for Biologics Evaluation and Research, FDA; (2) enzyme-linked immunosorbent assay replacement of radial immunodiffusion assays for potency determinations of cat and ragweed pollen allergen extracts by the Laboratory; (3) statistical considerations for the design and interpretation of phase III clinical trials of allergenic products; (4) environmental exposure chambers for phase III studies of allergenic products, and (5) International Organization for Standardization (ISO) 17025 accreditation of the Laboratory.
Blood Products Advisory Committee
Blood Products Advisory Committee
Committee Meeting on April 29, 2011, from 8:00 a.m. to 1 p.m. Day 2 of 2
Agenda: On April 29, 2011, in the morning, the committee will discuss blood donor written statement of understanding. In the afternoon, the Committee will hear an update from the Department of Health and Human Services'''' Office of the Assistant Secretary for Health and an update on public workshops FDA is considering sponsoring on thrombotic adverse events associated with Immune Globulin Intravenous, toxicities of Hydroxyethyl Starch Solutions, and measurement of hemoglobin in blood donors.
Committee Meeting on April 29, 2011, from 8:00 a.m. to 1 p.m. Day 2 of 2
Agenda: On April 29, 2011, in the morning, the committee will discuss blood donor written statement of understanding. In the afternoon, the Committee will hear an update from the Department of Health and Human Services'''' Office of the Assistant Secretary for Health and an update on public workshops FDA is considering sponsoring on thrombotic adverse events associated with Immune Globulin Intravenous, toxicities of Hydroxyethyl Starch Solutions, and measurement of hemoglobin in blood donors.
Blood Products Advisory Committee
Blood Products Advisory Committee
Committee Meeting on April 28, 2011, from 8:30 a.m. to 5:00 p.m.
Agenda: On April 28, 2011, in the morning, the committee will discuss testing donations of Source Plasma for hepatitis B virus infection by nucleic acid testing. In the afternoon, the committee will discuss current considerations on use of plasma obtained from Whole Blood donors for further manufacturing.
Committee Meeting on April 28, 2011, from 8:30 a.m. to 5:00 p.m.
Agenda: On April 28, 2011, in the morning, the committee will discuss testing donations of Source Plasma for hepatitis B virus infection by nucleic acid testing. In the afternoon, the committee will discuss current considerations on use of plasma obtained from Whole Blood donors for further manufacturing.
Antiviral Drugs Advisory Committee
Antiviral Drugs Advisory Committee
Committee Meeting on April 28, 2011, from 8 a.m. to 5:00 p.m.
Agenda: On April 28, 2011, the committee will discuss a new drug application (NDA) 201-917, telaprevir (a hepatitis C virus protease inhibitor), manufactured by Vertex Pharmaceuticals, Inc., with a proposed indication for the treatment of chronic hepatitis C genotype 1 infection, in combination with peginterferon alfa and ribavirin in adult patients with compensated liver disease who are previously untreated or who have failed previous therapy. Compensated liver disease is a stage in which the liver is damaged but maintains ability to function.
Committee Meeting on April 28, 2011, from 8 a.m. to 5:00 p.m.
Agenda: On April 28, 2011, the committee will discuss a new drug application (NDA) 201-917, telaprevir (a hepatitis C virus protease inhibitor), manufactured by Vertex Pharmaceuticals, Inc., with a proposed indication for the treatment of chronic hepatitis C genotype 1 infection, in combination with peginterferon alfa and ribavirin in adult patients with compensated liver disease who are previously untreated or who have failed previous therapy. Compensated liver disease is a stage in which the liver is damaged but maintains ability to function.
Antiviral Drugs Advisory Committee
Antiviral Drugs Advisory Committee
Committee Meeting on April 27, 2011, from 8 a.m. to 5:00 p.m.
Agenda: On April 27, 2011, the committee will discuss a new drug application (NDA) 202-258, boceprevir (a hepatitis C virus protease inhibitor), manufactured by Merck & Co., Inc., with a proposed indication for the treatment of chronic hepatitis C genotype 1 infection, in combination with peginterferon alfa and ribavirin in adult patients with compensated liver disease who are previously untreated or who have failed previous therapy. Compensated liver disease is a stage in which the liver is damaged but maintains ability to function.
Committee Meeting on April 27, 2011, from 8 a.m. to 5:00 p.m.
Agenda: On April 27, 2011, the committee will discuss a new drug application (NDA) 202-258, boceprevir (a hepatitis C virus protease inhibitor), manufactured by Merck & Co., Inc., with a proposed indication for the treatment of chronic hepatitis C genotype 1 infection, in combination with peginterferon alfa and ribavirin in adult patients with compensated liver disease who are previously untreated or who have failed previous therapy. Compensated liver disease is a stage in which the liver is damaged but maintains ability to function.
General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee
General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee
Committee Meeting on April 27, 2011, from 8 a.m. to 6 p.m.
Agenda: On April 27, 2011, the committee will discuss, make recommendations, and vote on information related to the premarket approval application supplement for RESTYLANE, sponsored by Medicis Aesthetics, Inc. RESTYLANE is currently approved for mid- to deep-dermal implantation for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds. The sponsor is requesting an expanded indication, to include use of RESTYLANE for augmentation of the lips.
Committee Meeting on April 27, 2011, from 8 a.m. to 6 p.m.
Agenda: On April 27, 2011, the committee will discuss, make recommendations, and vote on information related to the premarket approval application supplement for RESTYLANE, sponsored by Medicis Aesthetics, Inc. RESTYLANE is currently approved for mid- to deep-dermal implantation for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds. The sponsor is requesting an expanded indication, to include use of RESTYLANE for augmentation of the lips.
Oncologic Drugs Advisory Committee
Oncologic Drugs Advisory Committee
Committee Meeting on April 12, 2011, from 8:00 a.m. to 5:00 p.m.
Agenda: On April 12, 2011, during the morning session, the committee will discuss supplemental new drug application (sNDA) 022334/S-009, trade name AFINITOR (everolimus) tablets, application submitted by Novartis Pharmaceuticals Corp. The proposed indication(use) for this product is for the treatment of patients with advanced neuroendocrine tumors (NET)of gastrointestinal, lung, or pancreatic origin.
During the afternoon session, the committee will discuss sNDA 021938/S-013, trade name SUTENT (sunitinib malate) capsules, application submitted by C.P. Pharmaceuticals International C.V., represented by Pfizer, Inc. (authorized U.S. agent). The proposed indication (use) for this product is for the treatment of unresectable pancreatic neuroendocrine tumors (PNET).
Committee Meeting on April 12, 2011, from 8:00 a.m. to 5:00 p.m.
Agenda: On April 12, 2011, during the morning session, the committee will discuss supplemental new drug application (sNDA) 022334/S-009, trade name AFINITOR (everolimus) tablets, application submitted by Novartis Pharmaceuticals Corp. The proposed indication(use) for this product is for the treatment of patients with advanced neuroendocrine tumors (NET)of gastrointestinal, lung, or pancreatic origin.
During the afternoon session, the committee will discuss sNDA 021938/S-013, trade name SUTENT (sunitinib malate) capsules, application submitted by C.P. Pharmaceuticals International C.V., represented by Pfizer, Inc. (authorized U.S. agent). The proposed indication (use) for this product is for the treatment of unresectable pancreatic neuroendocrine tumors (PNET).
Vaccines and Related Biological Products Advisory Committee, Day 2 of 2
Vaccines and Related Biological Products Advisory Committee, Day 2 of 2
Committee Meeting on April 7, 2011, between approximately 8:30 a.m. and 3:30 p.m.
Agenda: On April 7, 2011, the committee will meet in open session to review and discuss approaches to licensure of meningococcal serogroup B vaccines.
Committee Meeting on April 7, 2011, between approximately 8:30 a.m. and 3:30 p.m.
Agenda: On April 7, 2011, the committee will meet in open session to review and discuss approaches to licensure of meningococcal serogroup B vaccines.
Vaccines and Related Biological Products Advisory Committee, Day 1 of 2
Vaccines and Related Biological Products Advisory Committee, Day 1 of 2
Committee Meeting on April 6, 2011, between approximately 9 a.m. and 4 p.m.
Agenda: On the morning of April 6, 2011, the committee will meet in open session to hear updates of the research programs in the Laboratory of Bacterial Polysaccharides, Division of Bacterial, Parasitic, and Allergenic Products, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, FDA. In the afternoon of April 6, 2011, the committee will meet in open session and will be briefed on the use of immunological markers for demonstration of effectiveness of meningococcal serogroups A, C, Y, and W-135 conjugate vaccines administered to children less than 2 years of age.
Committee Meeting on April 6, 2011, between approximately 9 a.m. and 4 p.m.
Agenda: On the morning of April 6, 2011, the committee will meet in open session to hear updates of the research programs in the Laboratory of Bacterial Polysaccharides, Division of Bacterial, Parasitic, and Allergenic Products, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, FDA. In the afternoon of April 6, 2011, the committee will meet in open session and will be briefed on the use of immunological markers for demonstration of effectiveness of meningococcal serogroups A, C, Y, and W-135 conjugate vaccines administered to children less than 2 years of age.
Anti-Infective Drugs Advisory Committee
Anti-Infective Drugs Advisory Committee
Committee Meeting on April 5, 2011, from 8:30 a.m. to 4:00 p.m.
Agenda: On April 5, 2011, the committee will discuss new drug application (NDA) 20-1699, for FIDAXOMICIN tablets, submitted by Optimer Pharmaceuticals, Inc., for the requested indication of treatment of adults with Clostridium difficile infection (CDI), also known as Clostridium difficile-associated diarrhea (CDAD), and prevention of recurrences.
Committee Meeting on April 5, 2011, from 8:30 a.m. to 4:00 p.m.
Agenda: On April 5, 2011, the committee will discuss new drug application (NDA) 20-1699, for FIDAXOMICIN tablets, submitted by Optimer Pharmaceuticals, Inc., for the requested indication of treatment of adults with Clostridium difficile infection (CDI), also known as Clostridium difficile-associated diarrhea (CDAD), and prevention of recurrences.
Tuesday, February 8, 2011
Neurological Devices Panel of the Medical Devices Advisory Committee
Neurological Devices Panel of the Medical Devices Advisory Committee
Meeting on March 18, 2011, from 8 a.m. to 6 p.m. (Day 2 of 2)
Agenda: On March 18, 2011, the committee will discuss, make recommendations and vote on information related to the PMA for the Pipeline Embolization Device (PED), sponsored by Chestnut Medical. The PED is indicated for the endovascular treatment of large or giant wide-necked intracranial aneurysms in the paraclinoid region of the internal carotid artery.
Meeting on March 18, 2011, from 8 a.m. to 6 p.m. (Day 2 of 2)
Agenda: On March 18, 2011, the committee will discuss, make recommendations and vote on information related to the PMA for the Pipeline Embolization Device (PED), sponsored by Chestnut Medical. The PED is indicated for the endovascular treatment of large or giant wide-necked intracranial aneurysms in the paraclinoid region of the internal carotid artery.
Neurological Devices Panel of the Medical Devices Advisory Committee
Neurological Devices Panel of the Medical Devices Advisory Committee
Meeting on March 17, 2011, from 8 a.m. to 6 p.m. (Day 1 of 2)
Agenda: On March 17, 2011, the committee will discuss, make recommendations and vote on information related to the premarket approval application (PMA) for the NovoTTF-100A Treatment Kit, sponsored by Hogan Lovells US LLP for NovoCure, Ltd. The NovoTTF-100A Treatment Kit is intended as a treatment for adult patients (greater than 21 years of age) with histologically- or radiologically-confirmed glioblastoma multiforme (GBM), following recurrence in the supra-tentorial region of the brain. The device is intended to be used as a monotherapy, after surgical and radiation options have been exhausted, in place of standard medical therapy for GBM.
Meeting on March 17, 2011, from 8 a.m. to 6 p.m. (Day 1 of 2)
Agenda: On March 17, 2011, the committee will discuss, make recommendations and vote on information related to the premarket approval application (PMA) for the NovoTTF-100A Treatment Kit, sponsored by Hogan Lovells US LLP for NovoCure, Ltd. The NovoTTF-100A Treatment Kit is intended as a treatment for adult patients (greater than 21 years of age) with histologically- or radiologically-confirmed glioblastoma multiforme (GBM), following recurrence in the supra-tentorial region of the brain. The device is intended to be used as a monotherapy, after surgical and radiation options have been exhausted, in place of standard medical therapy for GBM.
Anti-Infective Drugs Advisory Committee
Anti-Infective Drugs Advisory Committee
Committee Meeting on April 5, 2011, from 8:30 a.m. to 4:00 p.m.
Agenda: On April 5, 2011, the committee will discuss new drug application (NDA) 20-1699, for FIDAXOMICIN tablets, submitted by Optimer Pharmaceuticals, Inc., for the requested indication of treatment of adults with Clostridium difficile infection (CDI), also known as Clostridium difficile-associated diarrhea (CDAD), and prevention of recurrences.
Committee Meeting on April 5, 2011, from 8:30 a.m. to 4:00 p.m.
Agenda: On April 5, 2011, the committee will discuss new drug application (NDA) 20-1699, for FIDAXOMICIN tablets, submitted by Optimer Pharmaceuticals, Inc., for the requested indication of treatment of adults with Clostridium difficile infection (CDI), also known as Clostridium difficile-associated diarrhea (CDAD), and prevention of recurrences.
Tobacco Products Scientific Advisory Committee
Tobacco Products Scientific Advisory Committee
Committee Meeting on March 17 and 18 2011, from 8 a.m. to 5 p.m.
Agenda: On March 17 and 18, 2011, the committee will continue to receive updates from the Menthol Report Subcommittee and discuss plans for finalizing the report regarding the impact of use of menthol in cigarettes on the public health.
Committee Meeting on March 17 and 18 2011, from 8 a.m. to 5 p.m.
Agenda: On March 17 and 18, 2011, the committee will continue to receive updates from the Menthol Report Subcommittee and discuss plans for finalizing the report regarding the impact of use of menthol in cigarettes on the public health.
Tobacco Products Scientific Advisory Committee
Tobacco Products Scientific Advisory Committee
Committee Meeting on March 1 and 2 2011, from 8 a.m. until 5 p.m.
Agenda: On March 1 and 2, 2011, the Committee will continue to (1) receive updates from the Menthol Report Subcommittee and (2) receive and discuss presentations regarding the data requested by the Committee at the March 30 and 31, 2010, meeting of the Tobacco Products Advisory Committee.
Committee Meeting on March 1 and 2 2011, from 8 a.m. until 5 p.m.
Agenda: On March 1 and 2, 2011, the Committee will continue to (1) receive updates from the Menthol Report Subcommittee and (2) receive and discuss presentations regarding the data requested by the Committee at the March 30 and 31, 2010, meeting of the Tobacco Products Advisory Committee.
Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee
Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee
Committee Meeting on March 8 and 9 2011, from 8:00 a.m. to 6:00 p.m.
Agenda: On March 8 and 9, 2011, the committee will discuss and make recommendations on scientific issues concerning direct to consumer (DTC) genetic tests that make medical claims.
Committee Meeting on March 8 and 9 2011, from 8:00 a.m. to 6:00 p.m.
Agenda: On March 8 and 9, 2011, the committee will discuss and make recommendations on scientific issues concerning direct to consumer (DTC) genetic tests that make medical claims.
Tuesday, February 1, 2011
Advisory Committee for Pharmaceutical Science and Clinical Pharmacology
Advisory Committee for Pharmaceutical Science and Clinical Pharmacology
Committee Meeting on March 2, 2011, from 7:15 a.m. to 3 p.m.
Agenda: The committee will discuss innovative approaches to the development of drugs for orphan and rare diseases to support decisions such as dose and trial design selection. FDA will seek input and comment on how to optimally utilize mechanistic biomarkers and apply clinical pharmacology tools, such as pharmacogenetics and modeling and simulation, to facilitate efficient and informative drug development and regulatory review. FDA will present and seek input from the committee on how lessons learned from other applications of clinical pharmacology tools in pediatrics and oncology can be applied to orphan and rare disease drugs. The committee will be asked to comment on the current status and future direction for clinical pharmacology studies (e.g., dose-response, drug-drug interactions, pharmacokinetics in patients with renal or hepatic impairment) as they pertain to drug development for orphan and rare diseases
Committee Meeting on March 2, 2011, from 7:15 a.m. to 3 p.m.
Agenda: The committee will discuss innovative approaches to the development of drugs for orphan and rare diseases to support decisions such as dose and trial design selection. FDA will seek input and comment on how to optimally utilize mechanistic biomarkers and apply clinical pharmacology tools, such as pharmacogenetics and modeling and simulation, to facilitate efficient and informative drug development and regulatory review. FDA will present and seek input from the committee on how lessons learned from other applications of clinical pharmacology tools in pediatrics and oncology can be applied to orphan and rare disease drugs. The committee will be asked to comment on the current status and future direction for clinical pharmacology studies (e.g., dose-response, drug-drug interactions, pharmacokinetics in patients with renal or hepatic impairment) as they pertain to drug development for orphan and rare diseases
Monday, January 24, 2011
Peripheral and Central Nervous System Drugs Advisory Committee
Peripheral and Central Nervous System Drugs Advisory Committee
Committee Meeting on March 10, 2011, from 8 a.m. to 5 p.m.
Agenda: On March 10, 2011, the committee will discuss, in general, the use of historical-controlled trials for the approval of anticonvulsant monotherapy for seizures of partial origin for antiepileptic drug products that are already approved for adjunctive therapy. The committee will also discuss how this may specifically apply to the approval of the supplemental new drug application 022115/S–011, LAMICTAL XR (lamotrigine extended release tablets), sponsored by SmithKline Beecham Corp. d/b/a GlaxoSmithKline, for monotherapy in patients 13 years of age and older with partial seizures who are receiving therapy with a single antiepileptic drug.
Committee Meeting on March 10, 2011, from 8 a.m. to 5 p.m.
Agenda: On March 10, 2011, the committee will discuss, in general, the use of historical-controlled trials for the approval of anticonvulsant monotherapy for seizures of partial origin for antiepileptic drug products that are already approved for adjunctive therapy. The committee will also discuss how this may specifically apply to the approval of the supplemental new drug application 022115/S–011, LAMICTAL XR (lamotrigine extended release tablets), sponsored by SmithKline Beecham Corp. d/b/a GlaxoSmithKline, for monotherapy in patients 13 years of age and older with partial seizures who are receiving therapy with a single antiepileptic drug.
Anesthetic and Life Support Drugs Advisory Committee
Anesthetic and Life Support Drugs Advisory Committee
Committee Meeting on March 10, 2011, from 8 a.m. to 4:30 p.m.
Agenda: On March 10, 2011, the committee will: (1) Receive updates regarding neurodegenerative findings (findings related to degeneration in the nervous system) in juvenile animals exposed to anesthetic drugs, as well as results from human epidemiological studies using anesthesia in children (information related to studies of patterns and causes of disease); (2) discuss the relevance of these findings to pediatric patients and provide guidance for future preclinical and clinical studies; and (3) discuss the potential implications of these data upon the practice of pediatric anesthesia as well as the communication of the risk of sedative/anesthetic agents to prescribers and parents.
Committee Meeting on March 10, 2011, from 8 a.m. to 4:30 p.m.
Agenda: On March 10, 2011, the committee will: (1) Receive updates regarding neurodegenerative findings (findings related to degeneration in the nervous system) in juvenile animals exposed to anesthetic drugs, as well as results from human epidemiological studies using anesthesia in children (information related to studies of patterns and causes of disease); (2) discuss the relevance of these findings to pediatric patients and provide guidance for future preclinical and clinical studies; and (3) discuss the potential implications of these data upon the practice of pediatric anesthesia as well as the communication of the risk of sedative/anesthetic agents to prescribers and parents.
Pulmonary-Allergy Drugs Advisory Committee
Pulmonary-Allergy Drugs Advisory Committee
Committee Meeting on March 8, 2011, from 8 a.m. to 5 p.m.
Agenda: On March 8, 2011, the committee will discuss new drug application (NDA) 022-383, indacaterol maleate (ARCAPTA NEOHALER), by Novartis Pharmaceuticals Corp., for the long-term once daily maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease, including chronic bronchitis and/or emphysema.
Committee Meeting on March 8, 2011, from 8 a.m. to 5 p.m.
Agenda: On March 8, 2011, the committee will discuss new drug application (NDA) 022-383, indacaterol maleate (ARCAPTA NEOHALER), by Novartis Pharmaceuticals Corp., for the long-term once daily maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease, including chronic bronchitis and/or emphysema.
Vaccines and Related Biological Products Advisory Committee
Vaccines and Related Biological Products Advisory Committee
Committee Meeting on February 25, 2011, between approximately 8:30 a.m. and 1:50 p.m.
Agenda: On February 25, 2011, the committee will discuss and make recommendations on the selection of strains to be included in the influenza virus vaccine for the 2011-2012 influenza season. The committee will also hear an update on Pandemic Influenza Surveillance.
Committee Meeting on February 25, 2011, between approximately 8:30 a.m. and 1:50 p.m.
Agenda: On February 25, 2011, the committee will discuss and make recommendations on the selection of strains to be included in the influenza virus vaccine for the 2011-2012 influenza season. The committee will also hear an update on Pandemic Influenza Surveillance.
Menthol Report Subcommittee of the Tobacco Products Scientific Advisory Committee
Menthol Report Subcommittee of the Tobacco Products Scientific Advisory Committee
Committee Meeting on February 11, 2011, from 9 a.m. to 5 p.m.
Agenda: On February 11, 2011, the subcommittee will receive presentations and discuss the timelines and structure of the Tobacco Products Scientific Advisory Committee''s required report to the Secretary of Health and Human Services regarding the impact of use of menthol in cigarettes on the public health.
Committee Meeting on February 11, 2011, from 9 a.m. to 5 p.m.
Agenda: On February 11, 2011, the subcommittee will receive presentations and discuss the timelines and structure of the Tobacco Products Scientific Advisory Committee''s required report to the Secretary of Health and Human Services regarding the impact of use of menthol in cigarettes on the public health.
Tobacco Products Scientific Advisory Committee
Tobacco Products Scientific Advisory Committee
Committee Meeting on February 10, 2011, from 8 a.m. to 5 p.m.
Agenda: On February 10, 2011, the Committee will continue to do the following: (1) Receive updates from the Menthol Report Subcommittee and(2) receive and discuss presentations regarding the data requested by the Committee at the March 30 through 31, 2010, meeting of the Tobacco Products Scientific Advisory Committee.
Committee Meeting on February 10, 2011, from 8 a.m. to 5 p.m.
Agenda: On February 10, 2011, the Committee will continue to do the following: (1) Receive updates from the Menthol Report Subcommittee and(2) receive and discuss presentations regarding the data requested by the Committee at the March 30 through 31, 2010, meeting of the Tobacco Products Scientific Advisory Committee.
Circulatory System Devices Panel of the Medical Devices Advisory Committee
Circulatory System Devices Panel of the Medical Devices Advisory Committe
Committee Meeting on January 26, 2011 from 8 a.m. to 6 p.m.
Agenda: On January 26, 2011, the committee will discuss, make recommendations and vote on information related to the PMA supplement for the RX Acculink Carotid Stent System, sponsored by Abbott Vascular. The RX Acculink is indicated for treatment of patients at high and standard risk for adverse events from carotid endarterectomy who require carotid revascularization and meet the criteria outlined as follows:1. Patients with neurological symptoms and >50 percent stenosis of the common or internal carotid artery or patients without neurological symptoms and >80 percent (high risk) or >70 percent (standard risk) stenosis of the common or internal carotid artery and 2. Patients must have a reference vessel diameter within the range of 4.0 and 9.0 mm at the target lesion.
Committee Meeting on January 26, 2011 from 8 a.m. to 6 p.m.
Agenda: On January 26, 2011, the committee will discuss, make recommendations and vote on information related to the PMA supplement for the RX Acculink Carotid Stent System, sponsored by Abbott Vascular. The RX Acculink is indicated for treatment of patients at high and standard risk for adverse events from carotid endarterectomy who require carotid revascularization and meet the criteria outlined as follows:1. Patients with neurological symptoms and >50 percent stenosis of the common or internal carotid artery or patients without neurological symptoms and >80 percent (high risk) or >70 percent (standard risk) stenosis of the common or internal carotid artery and 2. Patients must have a reference vessel diameter within the range of 4.0 and 9.0 mm at the target lesion.
Circulatory System Devices Panel of the Medical Devices Advisory Committee
Circulatory System Devices Panel of the Medical Devices Advisory Committee
Committee Meeting on January 25, 2011 from 8 a.m. to 6 p.m.
Agenda: On January 25, 2011, the committee will discuss and make recommendations regarding regulatory classification of Automated External Defibrillators to either reconfirm to class III (subject to premarket approval application (PMA)) or reclassify to class II (subject to premarket notification (510(k))), as directed by section 515(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C 360e(i)).
Committee Meeting on January 25, 2011 from 8 a.m. to 6 p.m.
Agenda: On January 25, 2011, the committee will discuss and make recommendations regarding regulatory classification of Automated External Defibrillators to either reconfirm to class III (subject to premarket approval application (PMA)) or reclassify to class II (subject to premarket notification (510(k))), as directed by section 515(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C 360e(i)).
Oncologic Drugs Advisory Committee
Oncologic Drugs Advisory Committee
February 8, 2011, from 8 a.m. to 5 p.m.
Agenda: The committee will hear updates on new drug applications (NDAs) and biologics license applications (BLAs) approved under 21 CFR 314.500 and 601.40 (subpart H and subpart E, respectively, accelerated approval regulations) prior to January 1, 2009. These updates will provide information related to the status of phase IV clinical studies and to difficulties associated with completion of phase IV commitments. Phase IV studies are post marketing studies to confirm clinical benefit of a drug after it receives accelerated approval.
February 8, 2011, from 8 a.m. to 5 p.m.
Agenda: The committee will hear updates on new drug applications (NDAs) and biologics license applications (BLAs) approved under 21 CFR 314.500 and 601.40 (subpart H and subpart E, respectively, accelerated approval regulations) prior to January 1, 2009. These updates will provide information related to the status of phase IV clinical studies and to difficulties associated with completion of phase IV commitments. Phase IV studies are post marketing studies to confirm clinical benefit of a drug after it receives accelerated approval.
Neurological Devices Panel of the Medical Devices Advisory Committee
Neurological Devices Panel of the Medical Devices Advisory Committee
January 27th and 28th, 2011 from 8:00 a.m. to 6:00 p.m
Agenda: On January 27 and 28, 2011, the committee will discuss and make recommendations regarding the possible reclassification of devices indicated for use in electroconvulsive therapy.
January 27th and 28th, 2011 from 8:00 a.m. to 6:00 p.m
Agenda: On January 27 and 28, 2011, the committee will discuss and make recommendations regarding the possible reclassification of devices indicated for use in electroconvulsive therapy.
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