FOOD AND DRUG ADMINISTRATION

Center for Drug Evaluation and Research

ANTIVIRAL DRUGS ADVISORY COMMITTEE (AVAC) MEETING

TENTATIVE AGENDA

December 12, 2001

Holiday Inn –Bethesda, Maryland

 Topic: An update on the approval of BLA 103949/5002, PEG-Intron™ (peginterferon alfa-2b) Powder for Injection, indicated for use alone or in combination with Rebetol (ribavirin, USP) for the treatment of chronic hepatitis C in patients with compensated liver disease who have not been previously treated with interferon alpha and are at least 18 years of age.

8:15 a.m.          Call to Order                               Roy M. Gulick, M.D., M.P.H.
                                                   Chair, AVAC

                        Introduction of Committee

                        Conflict of Interest Statement       Tara P. Turner, Pharm.D.                                                                                                         Executive Secretary, AVAC

8:30 a.m.          Sponsor Presentation                Schering Corporation

9:00 a.m.          FDA Presentation                     Louis Marzella, M.D., Ph.D.
                                                                           Medical Officer
                                                                           Division of Clinical Trial Design and Analysis
                                                                           Center for Biologics Evaluation and Research
                                                                           FDA

9:30 a.m.          Committee Discussion              

10:00 a.m.        Open Public Hearing

11:00 a.m.        Committee Discussion

12:15 p.m.        Adjourn