DRAFT DRAFT DRAFT DRAFT
Food and Drug Administration
Center for Biologics Evaluation and Research
BIOLOGICAL RESPONSE MODIFIERS ADVISORY COMMITTEE
AGENDA
Meeting #31, Holiday Inn, Gaithersburg, MD
October 24, 2001
Wednesday, October 24
9:00 a.m. Opening Remarks
Dr. Daniel Salomon, Chair
9:10 Conflict of Interest Statement
Gail Dapolito, Executive Secretary
9:15 Introduction of Committee
OPEN COMMITTEE DISCUSSION
TOPIC: LONG-TERM FOLLOW-UP: GENE TRANSFER CLINICAL TRIAL PARTICIPANTS
9:20 FDA Introduction
Dr. Philippe Bishop, OTRR, CBER
Dr. Steven Rosenthal, OVRR, CBER
9:50 Q&A
10:05 Open Public Hearing
10:35 Break
11:00 Committee Discussion of Questions
12-1:00 p.m. Lunch
1-3:00 Committee Discussion of Question (cont’d if necessary)
2-3:00 Adjourn