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