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Advisory Committees

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Slides for the November 16, 2010 Meeting of the Arthritis Drugs Advisory Committee

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FDA

FDA Core Presentations, (BLA) 125370, BENLYSTA (belimumab) for the November 16, 2010 Meeting of the Arthritis Drugs Advisory Committee

Introduction:

Badrul Chowdhury, M.D., Ph.D., Director, Division of Pulmonary, Allergy and Rheumatology Products (DPARP), Office of Drug Evaluation (ODE) II, Office of New Drugs (OND), CDER, FDA (PDF - 70KB)

Main Presentation:

Rosemarie Neuner, M.D., Clinical Reviewer, DPARP, ODE II, OND, CDER, FDA; Ruthanna Davi, Ph.D., Statistical Reviewer, Division of Biometrics II, Office of Biostatistics, Office of Translational Science, CDER, FDA (PDF – 908KB)

Sponsor

Human Genome Sciences Core Presentations, (BLA) 125370, BENLYSTA (belimumab) for the November 16, 2010 Meeting of the Arthritis Drugs Advisory Committee (PDF – 4.6MB)

Human Genome Sciences, Backup Presentation Slides Shown (PDF – 5.9MB)

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