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U.S. Department of Health and Human Services

Advisory Committees

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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

 

Persons with disabilities having problems accessing the PDF file(s) below may call (301) 796-3634 for assistance

 

FDA

  

FDA Core Presentations, 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 – 240 KB)

 

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

 

Thomas A. Marciniak, M.D., Medical Team Leader, Division of Cardiovascular and Renal Products, CDER, FDA (PDF – 942 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 – 365 KB)

David Graham, M.D., Associate Director for Science and Medicine, OSE, FDA 2. (PDF – 332 KB)

 

Fiona Callaghan, Ph.D., Office of Biostatistics, Office of Translational Sciences, CDER, FDA (PDF – 156 KB)
 

Brad McEvoy, Dr.P.H., Office of Biostatistics, Office of Translational Sciences, CDER, FDA (PDF – 544 KB)

 

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)

 

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

 

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)

 

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 – 2.64 MB)

 

 

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 – 98 KB)