Advisory Committees

Final 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

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FDA

FDA 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

Mary H. Parks, M.D., Director, Division of Metabolism and Endocrinology Products (DMEP) (PDF - 239KB)

Thomas A. Marciniak, M.D., Medical Team Leader, Division of Cardiovascular and Renal Products, CDER, FDA (PDF – 941 KB)

Ellis F. Unger, M.D., Deputy Director, Office of Drug Evaluation-I (ODE I), Office of New Drugs (OND), CDER, FDA (PDF – 215 KB)

Karen M. Mahoney, M.D., Clinical Reviewer, DMEP, CDER, FDA (PDF – 726 KB)

David Hoberman, Ph.D., Mathematical Statistician, Division of Biometrics II, CDER, FDA (PDF – 31 KB)

Susan Leibenhaut, M.D., Medical Officer, Good Clinical Practice Branch 2, Division of Scientific Investigations, Office of Compliance, CDER, FDA (PDF – 121 KB)

Kate Gelperin, M.D., Medical Officer, Division of Epidemiology, Office of Surveillance and Epidemiology (OSE), FDA (PDF – 525 KB)

David Graham, M.D., Associate Director for Science and Medicine, OSE, FDA 1. (PDF – 364 KB)

David Graham, M.D., Associate Director for Science and Medicine, OSE, FDA 2. (PDF – 331 KB)

Fiona Callaghan, Ph.D., Office of Biostatistics, Office of Translational Sciences, CDER, FDA (PDF – 155 KB)

Brad McEvoy, Dr.P.H., Office of Biostatistics, Office of Translational Sciences, CDER, FDA (PDF – 543 KB)

Guest Speakers

Day 1

Steven Nissen, M.D. (Guest Speaker),Cleveland Clinic, Cleveland, Ohio (PDF – 2.08 MB)

Maria Mori Brooks, Ph.D. (Guest Speaker), Associate Professor of Epidemiology and Biostatistics, University of Pittsburgh (PDF – 527 KB)

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)

Day 2

Hertzel Gerstein, M.D. (Guest Speaker), McMaster University Dept. of Medicine, Hamilton, Ontario, Canada (PDF – 269 KB)

Dean Follmann, Ph.D. (Guest Speaker), Mathematical Statistician, Biostatistics Research Branch, National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (PDF - 295 KB)

Sponsors

GlaxoSmithKline

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 – 2.75 MB)

Takeda Pharmaceuticals, Inc.

Takeda Pharmaceuticals Backup Slide Presentation 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 – 99.5 KB)

Open Public Hearing

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 – 97 KB)

OPH 2 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 – 1.44 MB)

OPH 3 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 – 60 KB)

OPH 4 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 – 107 KB)

OPH 5 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 – 323 KB)

Advisory Committees

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Final 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

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