November 14, 2001
Advisors and Consultants Staff
Food and Drug Administration
Center for Drug Evaluation and Research
Office of Regulatory Management
HFD-21, Room 1093
5630 Fishers Lane
Rockville, MD 20852-1734
SUBJECT: MATERIAL FOR THE ANTIVIRAL ADVISORY COMMITTEE MEETING DECEMBER 12, 2001
In response to the Agency letter dated October 30, 2001, Schering is providing for distribution to the Antiviral Advisory Committee 35 copies of the publications based on the results of the hepatitis pivotal clinical trial programs for REBETRONTM, PEG-INTRONTM and PEG-INTRONTM/REBETOLÒ . The publications included are:
As the material is copyrighted by the journal in which it was published, it is not being provided electronically.
Please contact Ms. Rachael Steiner (908-740-2565) or Dr. Penny Giles (908-740-2340) for additional information.
Joseph F. Lamendola, Ph.D.
U.S. Regulatory Affairs