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.
Wednesday, October 26, 2011
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.
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