Food and Drug Administration
Center for Drug Evaluation and Research (CDER)
Antiviral Drugs Advisory Committee
Slides Presented at Meeting
Overview of Issues Debra
B. Birnkrant, M.D.
Director,
Division of Antiviral Drug Products (DAVDP)
Sponsor
Presentations
Bristol-Myers Squibb Company
Bristot-Meyers
Scuibb Company Backup Slides
FDA Presentations
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