FOOD AND DRUG ADMINISTRATION
CENTER FOR BIOLOGICS EVALUATION AND RESEARCH
VACCINES AND RELATED BIOLOGICAL PRODUCTS ADVISORY COMMITTEE
July 26-27, 2001
Holiday Inn, 2 Montgomery Village Avenue, Gaithersburg, Maryland
Preliminary AGENDA
Thursday, July 26
9:00 am Session 1 - CLOSED SESSION
10:15 Session 2 - OPEN Session
10:30 Call to Order, Dr. Robert S. Daum,
Introductions, Administrative Matters Committee Chair
10:45 Introduction to Session and Summary
of Prior VRBPAC Deliberations Dr. Peter Patriarca, FDA
11:15 Overview of Development of Cold-adapted,
Live Attenuated Influenza Vaccines; Basis for
Attenuation; and Potential for Reassortment
with Wild-type Viruses in Nature Dr. Brian Murphy, NIH
12:00 Q&A on Dr. Murphy’s Presentation
12:15pm Lunch
1:15 Sponsor’s Presentation with Q&A TBD
2:45 Break
3:00 FDA Presentation with Q&A Dr. Chris Mink, FDA
4:15 Adjourn for the Day
FOOD AND DRUG ADMINISTRATION
CENTER FOR BIOLOGICS EVALUATION AND RESEARCH
VACCINES AND RELATED BIOLOGICAL PRODUCTS ADVISORY COMMITTEE
July 26-27, 2001
Holiday Inn, 2 Montgomery Village Avenue, Gaithersburg, Maryland
Preliminary AGENDA, continued
Friday, July 27
Session 2 -continued
8:30 am Call to Order, Dr. Robert S. Daum,
Administrative Matters Committee Chair
8:40 Summary of Issues and Presentation of
Questions to and Discussion Points for the
Committee Dr. Roland Levandowski, FDA
9:00 Open Public Hearing
10:15 Committee Discussion and Voting
12:00 noon Lunch
1:00 Committee Discussion and Voting, continued
3:30 pm Adjourn