Food and Drug Administration

Center for Drug Evaluation and Research (CDER)

Antiviral Drugs Advisory Committee

March 11, 2005

Slides Presented at Meeting

Overview of Issues Debra B. Birnkrant, M.D.
Director, Division of Antiviral Drug Products (DAVDP)

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Sponsor Presentations

Bristol-Myers Squibb Company

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Bristot-Meyers Scuibb Company Backup Slides

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FDA Presentations

Carcinogenicity Issues James G. Farrelly, Ph.D.

Pharmacology Team Leader, DAVDP

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Clinical Issues Linda L. Lewis, M.D.

Lead Medical Officer, DAVDP

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Questions to the Committee

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