Pulmonary - Allergy Drugs Advisory Committee
Meeting on February 23, 2012, from 8:30 a.m. to 5 p.m.
Agenda: The committee will discuss new drug application 202450, for aclidinium bromide, sponsored by Forest Laboratories, for the proposed indication of long-term maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease, including chronic bronchitis and emphysema.
Tuesday, January 31, 2012
Blood Products Advisory Committee
Blood Products Advisory Committee
Meeting on February 29, 2012, from 8:30 a.m. to 4 p.m.
Agenda: On February 29, 2012, the committee will discuss the evaluation of possible new plasma products manufactured following storage at room temperature for up to 24 hours, namely, plasma for transfusion prepared from whole blood held at room temperature for up to 24 hours prior to separation and freezing, or from apheresis plasma held at room temperature for up to 24 hours before freezing. In the afternoon, the committee will hear the following updates: Report from the Health and Human Services Advisory Committee on Blood Safety and Availability and summary of the December 5–6, 2011, meeting; update on HHS activities related to the evaluation of the donor deferral policy for men who have had sex with other men; summary of the November 8–9, 2011, public workshop on hemoglobin standard and maintaining an adequate blood supply; summary of the November 29, 2011, public workshop on data and data needs to advance risk assessment for emerging infectious diseases for blood and blood products; and an update on thrombotic adverse events and immune globulin products.
Meeting on February 29, 2012, from 8:30 a.m. to 4 p.m.
Agenda: On February 29, 2012, the committee will discuss the evaluation of possible new plasma products manufactured following storage at room temperature for up to 24 hours, namely, plasma for transfusion prepared from whole blood held at room temperature for up to 24 hours prior to separation and freezing, or from apheresis plasma held at room temperature for up to 24 hours before freezing. In the afternoon, the committee will hear the following updates: Report from the Health and Human Services Advisory Committee on Blood Safety and Availability and summary of the December 5–6, 2011, meeting; update on HHS activities related to the evaluation of the donor deferral policy for men who have had sex with other men; summary of the November 8–9, 2011, public workshop on hemoglobin standard and maintaining an adequate blood supply; summary of the November 29, 2011, public workshop on data and data needs to advance risk assessment for emerging infectious diseases for blood and blood products; and an update on thrombotic adverse events and immune globulin products.
Vaccines and Related Biological Products Advisory Committee
Vaccines and Related Biological Products Advisory Committee
Committee Meeting February 29, 2012 between 8:00 a.m. and 1:00 p.m (Day 2 of 2)
Agenda: On February 29, 2012 the committee will discuss licensure pathways for pandemic influenza vaccines.
Committee Meeting February 29, 2012 between 8:00 a.m. and 1:00 p.m (Day 2 of 2)
Agenda: On February 29, 2012 the committee will discuss licensure pathways for pandemic influenza vaccines.
Vaccines and Related Biological Products Advisory Committee
Vaccines and Related Biological Products Advisory Committee
Meeting on February 28, 2012 between approximately 8:00 a.m. and 4:00 p.m (Day 1 of 2)
Agenda: On February 28, 2012, the committee will hear an overview of the research program in the Laboratory of Mycobacterial Diseases and Cellular Immunology, Division of Bacterial, Parasitic and Allergenic Products, Office of Vaccines Research and Review, Center of Biologics Evaluation and Research, FDA. The committee will then discuss and make recommendations on the selection of strains to be included in the influenza virus vaccine for the 2012-2013 influenza season. The committee will also hear an update on Pandemic Influenza Surveillance.
Meeting on February 28, 2012 between approximately 8:00 a.m. and 4:00 p.m (Day 1 of 2)
Agenda: On February 28, 2012, the committee will hear an overview of the research program in the Laboratory of Mycobacterial Diseases and Cellular Immunology, Division of Bacterial, Parasitic and Allergenic Products, Office of Vaccines Research and Review, Center of Biologics Evaluation and Research, FDA. The committee will then discuss and make recommendations on the selection of strains to be included in the influenza virus vaccine for the 2012-2013 influenza season. The committee will also hear an update on Pandemic Influenza Surveillance.
Friday, January 13, 2012
Advisory Committee for Pharmaceutical Science and Clinical Pharmacology
Advisory Committee for Pharmaceutical Science and Clinical Pharmacology
Meeting on March 14, 2012, from 7:30 a.m. to 3 p.m.
Agenda: The committee will discuss the clinical pharmacology aspects of pediatric clinical trial design and dosing to optimize pediatric drug development. FDA will seek input on how to strategically inform pediatric clinical trial design and dosing by utilizing existing knowledge, including available adult and nonclinical data. The discussion will include the role of modeling and simulation including physiologically-based pharmacokinetic modeling in pediatric drug development. Modeling and simulation is the application of mathematical approaches to predicting what will happen in a clinical trial with pediatric patients when a particular dose of a drug is used.
Meeting on March 14, 2012, from 7:30 a.m. to 3 p.m.
Agenda: The committee will discuss the clinical pharmacology aspects of pediatric clinical trial design and dosing to optimize pediatric drug development. FDA will seek input on how to strategically inform pediatric clinical trial design and dosing by utilizing existing knowledge, including available adult and nonclinical data. The discussion will include the role of modeling and simulation including physiologically-based pharmacokinetic modeling in pediatric drug development. Modeling and simulation is the application of mathematical approaches to predicting what will happen in a clinical trial with pediatric patients when a particular dose of a drug is used.
Arthritis Advisory Committee
Arthritis Advisory Committee
Meeting on March 12, 2012, from 8 a.m. to 5:30 p.m.
Agenda: 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, post-herpetic 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 March 12, 2012, from 8 a.m. to 5:30 p.m.
Agenda: 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, post-herpetic 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.
Tuesday, January 3, 2012
Cardiovascular and Renal Drugs Advisory Committee
Cardiovascular and Renal Drugs Advisory Committee
Committee Meeting on February 23, 2012 from 8:00 a.m. to 5:00 p.m.
Agenda: The committee will discuss new drug application (NDA) 203202, proposed trade name NORTHERA (droxidopa capsules), submitted by Chelsea Therapeutics, Inc., for the treatment of symptomatic neurogenic orthostatic hypotension in patients with primary autonomic failure (Parkinson''''s Disease, Multiple System Atrophy, and Pure Autonomic Failure), Dopamine Beta-Hydroxylase Deficiency, and Non-Diabetic Autonomic Neuropathy.
Committee Meeting on February 23, 2012 from 8:00 a.m. to 5:00 p.m.
Agenda: The committee will discuss new drug application (NDA) 203202, proposed trade name NORTHERA (droxidopa capsules), submitted by Chelsea Therapeutics, Inc., for the treatment of symptomatic neurogenic orthostatic hypotension in patients with primary autonomic failure (Parkinson''''s Disease, Multiple System Atrophy, and Pure Autonomic Failure), Dopamine Beta-Hydroxylase Deficiency, and Non-Diabetic Autonomic Neuropathy.
Endocrinologic and Metabolic Drugs Advisory Committee
Endocrinologic and Metabolic Drugs Advisory Committee
Committee Meeting on February 22, 2012 from 8:00 a.m. to 5:00 p.m.
Agenda: On February 22, 2012, the committee will discuss the safety and efficacy of new drug application (NDA) 22-580, proposed trade name QNEXA (phentermine/topiramate) Controlled-Release Capsules, manufactured by VIVUS, Inc., as an adjunct to diet and exercise for weight management in patients with a body mass index (BMI) equal to or greater than 30 kilograms (kg) per square meter or a BMI equal to or greater than 27 kg per square meter if accompanied by weight-related comorbidities.
Committee Meeting on February 22, 2012 from 8:00 a.m. to 5:00 p.m.
Agenda: On February 22, 2012, the committee will discuss the safety and efficacy of new drug application (NDA) 22-580, proposed trade name QNEXA (phentermine/topiramate) Controlled-Release Capsules, manufactured by VIVUS, Inc., as an adjunct to diet and exercise for weight management in patients with a body mass index (BMI) equal to or greater than 30 kilograms (kg) per square meter or a BMI equal to or greater than 27 kg per square meter if accompanied by weight-related comorbidities.
Anesthetic and Analgesic Drug Products Advisory Committee
Anesthetic and Analgesic Drug Products Advisory Committee,
Committee Meeting on February 9, 2012, from 8:30 a.m. to 4 p.m.
Agenda: The committee will discuss the available efficacy and safety data for supplemental new drug application (sNDA) 22395/S-013, QUTENZA (capsaicin 8%) Patch, by NeurogesX, Inc., for the proposed indication of management of neuropathic pain (nerve pain) related to HIV-associated peripheral neuropathy (nerve pain in the periphery of the body, such as the feet and legs).
Committee Meeting on February 9, 2012, from 8:30 a.m. to 4 p.m.
Agenda: The committee will discuss the available efficacy and safety data for supplemental new drug application (sNDA) 22395/S-013, QUTENZA (capsaicin 8%) Patch, by NeurogesX, Inc., for the proposed indication of management of neuropathic pain (nerve pain) related to HIV-associated peripheral neuropathy (nerve pain in the periphery of the body, such as the feet and legs).
Oncologic Drugs Advisory Committee
Oncologic Drugs Advisory Committee
Committee Meeting on February 9, 2012 from 8:00 a.m. to 5:00 p.m. (Day 2 of 2)]
Agenda: On February 9, 2012, during the morning session, the committee will discuss supplemental new drug application (NDA) 21790/010 for DACOGEN (decitabine) for injection, application submitted by Eisai, Inc. The proposed indication (use) for this product is for the treatment of acute myelogenous leukemia (AML) in adults 65 years of age or older who are not considered candidates for induction chemotherapy, which is the standard first phase of treatment for AML.
During the afternoon session, the committee will discuss NDA 022481, with the proposed trade name PIXUVRI (pixantrone dimaleate) injection, application submitted by Cell Therapeutics, Inc. The proposed indication (use) for this product is as a single agent treatment for patients with relapsed or refractory (difficult to treat), aggressive Non-Hodgkin’s Lymphoma who received two or more prior lines of therapy.
Committee Meeting on February 9, 2012 from 8:00 a.m. to 5:00 p.m. (Day 2 of 2)]
Agenda: On February 9, 2012, during the morning session, the committee will discuss supplemental new drug application (NDA) 21790/010 for DACOGEN (decitabine) for injection, application submitted by Eisai, Inc. The proposed indication (use) for this product is for the treatment of acute myelogenous leukemia (AML) in adults 65 years of age or older who are not considered candidates for induction chemotherapy, which is the standard first phase of treatment for AML.
During the afternoon session, the committee will discuss NDA 022481, with the proposed trade name PIXUVRI (pixantrone dimaleate) injection, application submitted by Cell Therapeutics, Inc. The proposed indication (use) for this product is as a single agent treatment for patients with relapsed or refractory (difficult to treat), aggressive Non-Hodgkin’s Lymphoma who received two or more prior lines of therapy.
Oncologic Drugs Advisory Committee
Oncologic Drugs Advisory Committee
Committee Meeting on February 8, 2012 from 8:00 a.m. to 12:30 p.m. (Day 1 of 2)]
Agenda: The committee will discuss supplemental biologics license application 125320/28 for XGEVA (denosumab) injection, application submitted by Amgen Inc. The proposed indication (use) for this product is for the treatment of men with castrate-resistant prostate cancer at high risk of developing bone metastases, or spread of cancer to the bones.
Committee Meeting on February 8, 2012 from 8:00 a.m. to 12:30 p.m. (Day 1 of 2)]
Agenda: The committee will discuss supplemental biologics license application 125320/28 for XGEVA (denosumab) injection, application submitted by Amgen Inc. The proposed indication (use) for this product is for the treatment of men with castrate-resistant prostate cancer at high risk of developing bone metastases, or spread of cancer to the bones.
Pediatric Advisory Committee
Pediatric Advisory Committee
Committee Meeting on January 30, 2012 from 9 a.m. to 12 p.m. (Day 2 of 2)]
Agenda: 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 Prevnar 13 (Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein), Cervarix (Human Papillomavirus Bivalent (Types 16 and 18) vaccine, recombinant, Focalin XR (dexmethylphenidate), Daytrana (methylphenidate), Seroquel (quetiapine), Pancreaze (pancrelipase), Zenpep (pancrelipase), Creon (pancrelipase), Xerese cream 5%/1% (acyclovir and hydrocortisone), Xolair (omalizumab), Benicar (olmesartan medoxomil), Atacand (candesartan cilexetil), Mirena (levonorgestrel— releasing intrauterine system), Plan B One Step (levonorgestrel), and Flomax (tamsulosin).
Committee Meeting on January 30, 2012 from 9 a.m. to 12 p.m. (Day 2 of 2)]
Agenda: 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 Prevnar 13 (Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein), Cervarix (Human Papillomavirus Bivalent (Types 16 and 18) vaccine, recombinant, Focalin XR (dexmethylphenidate), Daytrana (methylphenidate), Seroquel (quetiapine), Pancreaze (pancrelipase), Zenpep (pancrelipase), Creon (pancrelipase), Xerese cream 5%/1% (acyclovir and hydrocortisone), Xolair (omalizumab), Benicar (olmesartan medoxomil), Atacand (candesartan cilexetil), Mirena (levonorgestrel— releasing intrauterine system), Plan B One Step (levonorgestrel), and Flomax (tamsulosin).
Pediatric Advisory Committee
Pediatric Advisory Committee
Committee Meeting on January 30, 2012 from 8 a.m. to 4 p.m. (Day 1 of 2)]
Agenda: 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 Prevnar 13 (Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein), Cervarix (Human Papillomavirus Bivalent (Types 16 and 18) vaccine, recombinant, Focalin XR (dexmethylphenidate), Daytrana (methylphenidate), Seroquel (quetiapine), Pancreaze (pancrelipase), Zenpep (pancrelipase), Creon (pancrelipase), Xerese cream 5%/1% (acyclovir and hydrocortisone), Xolair (omalizumab), Benicar (olmesartan medoxomil), Atacand (candesartan cilexetil), Mirena (levonorgestrel— releasing intrauterine system), Plan B One Step (levonorgestrel), and Flomax (tamsulosin).
Committee Meeting on January 30, 2012 from 8 a.m. to 4 p.m. (Day 1 of 2)]
Agenda: 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 Prevnar 13 (Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein), Cervarix (Human Papillomavirus Bivalent (Types 16 and 18) vaccine, recombinant, Focalin XR (dexmethylphenidate), Daytrana (methylphenidate), Seroquel (quetiapine), Pancreaze (pancrelipase), Zenpep (pancrelipase), Creon (pancrelipase), Xerese cream 5%/1% (acyclovir and hydrocortisone), Xolair (omalizumab), Benicar (olmesartan medoxomil), Atacand (candesartan cilexetil), Mirena (levonorgestrel— releasing intrauterine system), Plan B One Step (levonorgestrel), and Flomax (tamsulosin).
Pediatric Advisory Committee
Pediatric Advisory Committee
Committee Meeting on January 30, 2012 from 8 a.m. to 4 p.m. (Day 1 of 2)]
Agenda: 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 Prevnar 13 (Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein), Cervarix (Human Papillomavirus Bivalent (Types 16 and 18) vaccine, recombinant, Focalin XR (dexmethylphenidate), Daytrana (methylphenidate), Seroquel (quetiapine), Pancreaze (pancrelipase), Zenpep (pancrelipase), Creon (pancrelipase), Xerese cream 5%/1% (acyclovir and hydrocortisone), Xolair (omalizumab), Benicar (olmesartan medoxomil), Atacand (candesartan cilexetil), Mirena (levonorgestrel— releasing intrauterine system), Plan B One Step (levonorgestrel), and Flomax (tamsulosin).
Committee Meeting on January 30, 2012 from 8 a.m. to 4 p.m. (Day 1 of 2)]
Agenda: 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 Prevnar 13 (Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein), Cervarix (Human Papillomavirus Bivalent (Types 16 and 18) vaccine, recombinant, Focalin XR (dexmethylphenidate), Daytrana (methylphenidate), Seroquel (quetiapine), Pancreaze (pancrelipase), Zenpep (pancrelipase), Creon (pancrelipase), Xerese cream 5%/1% (acyclovir and hydrocortisone), Xolair (omalizumab), Benicar (olmesartan medoxomil), Atacand (candesartan cilexetil), Mirena (levonorgestrel— releasing intrauterine system), Plan B One Step (levonorgestrel), and Flomax (tamsulosin).
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