FOOD AND DRUG ADMINISTRATION
Center for Drug Evaluation and Research
ANTIVIRAL DRUGS ADVISORY COMMITTEE (AVAC) MEETING
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.
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.
Division of Clinical Trial Design and Analysis
Center for Biologics Evaluation and Research
9:30 a.m. Committee Discussion
10:00 a.m. Open Public Hearing
11:00 a.m. Committee Discussion
12:15 p.m. Adjourn