Food and Drug Administration
Center for Drug Evaluation and Research (CDER)
Antiviral Drugs Advisory Committee
Overview of Issues Debra
B. Birnkrant, M.D.
Director, Division of Antiviral Drug Products (DAVDP)
Bristol-Myers Squibb Company
Bristot-Meyers Scuibb Company Backup Slides
Carcinogenicity Issues James G. Farrelly, Ph.D.
Pharmacology Team Leader, DAVDP
Clinical Issues Linda L. Lewis, M.D.
Lead Medical Officer, DAVDP
Questions to the Committee