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Advisory Committees
Recently Updated Advisory Committee Materials
Posted on July 14, 2010
Advisory Committee Calendar
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Posted on July 13, 2010
Endocrinologic and Metabolic Drugs Advisory Committee
- FDA Briefing Information, (NDA) 22–580, proposed tradename, QNEXA (phentermine/topiramate) Controlled Release Capsules, for the July 15, 2010 Joint Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee (PDF – 9.72MB) (PDF - 9953KB)
- Draft Questions for the July 15, 2010 Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee (PDF - 269KB)
- VIVUS, Inc. Briefing Information, (NDA) 22–580, proposed tradename, QNEXA (phentermine/topiramate) Controlled Release Capsules, for the July 15, 2010 Joint Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee (PDF – 3.77MB) (PDF - 3865KB)
- Draft Agenda for the July 15, 2010 Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee (PDF - 43KB)
- FDA Briefing Information, (NDA) 22–580, proposed tradename, QNEXA (phentermine/topiramate) Controlled Release Capsules, for the July 15, 2010 Joint Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee (PDF – 4.02MB) (PDF - 9953KB)
- Draft Meeting Roster for the July 15, 2010 Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee (PDF - 82KB)
- Briefing Information for the July 15, 2010 Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee
- 2010 Meeting Materials, Endocrinologic and Metabolic Drugs Advisory Committee
Advisory Committee Calendar
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Posted on July 12, 2010
Pediatric Advisory Committee
- Minutes of the June 21, 2010 Meeting of the Pediatric Advisory Committee (PDF - 71KB)
- Final Agenda for the June 21, 2010 Meeting of the Pediatric Advisory Committee
- 2010 Meeting Materials, Pediatric Advisory Committee to the Food and Drug Administration
Reproductive Health Drugs Advisory Committee
Pulmonary-Allergy Drugs Advisory Committee
Psychopharmacologic Drugs Advisory Committee
Pharmaceutical Science and Clinical Pharmacology Advisory Committee
Peripheral and Central Nervous System Drugs Advisory Committee
Oncologic Drugs Advisory Committee
Nonprescription Drugs Advisory Committee
Gastrointestinal Drugs Advisory Committee
Endocrinologic and Metabolic Drugs Advisory Committee
Drug Safety and Risk Management Advisory Committee
Dermatologic and Ophthalmic Drugs Advisory Committee
Cardiovascular and Renal Drugs Advisory Committee
Arthritis Advisory Committee
Antiviral Drugs Advisory Committee
Anti-Infective Drugs Advisory Committee
Anesthetic and Life Support Drugs Advisory Committee
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Posted on July 09, 2010
Reproductive Health Drugs Advisory Committee
- 2010 Meeting Materials, Reproductive Health Drugs Advisory Committee
- Transcript for the June 17, 2010 Meeting of the Advisory Committee for Reproductive Health Drugs (PDF - 675KB)
Endocrinologic and Metabolic Drugs Advisory Committee
- Karen M. Mahoney, M.D., Clinical Reviewer, DMEP, CDER, FDA (PDF – 726 KB) (PDF - 726KB)
- FDA Briefing Information, AVANDIA (Rosiglitazone Maleate) Tablets, for the July 13-14, 2010 Joint Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee (PDF –24MB) (PDF - 37648KB)
- GSK Briefing Information, AVANDIA (Rosiglitazone Maleate) Tablets, for the July 13-14, 2010 Joint Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee (PDF –5MB) (PDF - 5206KB)
- Brad McEvoy, Dr.P.H., Office of Biostatistics, Office of Translational Sciences, CDER, FDA (PDF – 544 KB) (PDF - 543KB)
- Briefing Information for the July 13-14, 2010 Joint Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee
- Steven Nissen, M.D., Cleveland Clinic, Cleveland, Ohio (PDF – 2.08 MB) (PDF - 2131KB)
- David Graham, M.D., Associate Director for Science and Medicine, OSE, FDA 2. (PDF – 332 KB) (PDF - 332KB)
- OPH 1 for the July 13-14, 2010 Joint Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee (PDF – 98 KB) (PDF - 97KB)
- Pre-Meeting Posting of Slides for the July 13-14, 2010 Joint Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee
- Thomas A. Marciniak, M.D., Medical Team Leader, Division of Cardiovascular and Renal Products, CDER, FDA (PDF – 942 KB) (PDF - 942KB)
- Thomas Moritz, M.S. (Guest Speaker), Acting Associate Director for Scientific and Technical Operations, Edward Hines Jr. VA Hospital/Research Service/Cooperative Studies Program Coordinating Center (CSPCC) (PDF – 526 KB) (PDF - 526KB)
- Draft Meeting Roster for the July 13-14, 2010 Joint Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee (PDF - 105KB)
- Dean Follman, Ph.D. (Guest Speaker),Mathematical Statistician, Biostatistics Research Branch, National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH) (PDF - 296 KB) (PDF - 198KB)
- David Graham, M.D., Associate Director for Science and Medicine, OSE, FDA 1. (PDF – 365 KB) (PDF - 365KB)
- Maria Mori Brooks, Ph.D. (Guest Speaker), Associate Professor of Epidemiology and Biostatistics, University of Pittsburgh (PDF – 527 KB) (PDF - 527KB)
- Susan Leibenhaut, M.D., Medical Officer, Good Clinical Practice Branch 2, Division of Scientific Investigations, Office of Compliance, CDER, FDA (PDF – 121 KB) (PDF - 122KB)
- GlaxoSmithKline Core Presentations, AVANDIA (rosiglitazone maleate) Tablets, for the July 13-14, 2010 Joint Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee (PDF – 2.64 MB) (PDF - 2713KB)
- Report of the Instutute of Medicine (PDF - 184KB)
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