Food And Drug
Administration
Center For
Biologics Evaluation And Research
Vaccines And Related
Biological Products Advisory Committee Meeting
DRAFT AGENDA (11/29)
Day 1
9:00 a.m. Call to Order and Opening Remarks Gary D. Overturf, M.D., Chair
9:05 Presentation of Appreciation Plaques to Norman W. Baylor, Ph.D., FDA
Retiring Members
9:10 Administrative Matters
Christine
Walsh, R.N., FDA
Safety and Efficacy of Rotavirus Vaccine Manufactured by Merck
9:20 a.m. FDA Brief Introduction Rosemary Tiernan, M.D., M.P.H., FDA
Presentation of Questions
9:30 Sponsor Presentation Mark Bagarazzi, M.D./
Penny Heaton, M.D., M.P.H.
Merck Research Laboratories
10:30 Break
10:45 FDA Presentation Rosemary
Tiernan, M.D., M.P.H., FDA
Hector Izurieta, M.D., M.P.H., FDA
11:45 Lunch
4:30 p.m. Adjourn for the day
Food And Drug
Administration
Center For
Biologics Evaluation And Research
Vaccines And Related
Biological Products Advisory Committee Meeting
DRAFT AGENDA (11/29)
Day 2
9:00 a.m. Call to Order and Opening Remarks Gary D. Overturf, M.D., Chair
9:05 Administrative Matters Christine Walsh, R.N., FDA
Safety and Efficacy of ZOSTAVAX (Zoster Vaccine Live [Oka/Merck] ) Manufactured by Merck
9:20 a.m. FDA Brief Introduction Patricia Rohan, M.D., FDA
Presentation of Questions
9:30 Sponsor Presentation David Gutsch, M.D./
Jeffrey Silber, M.D.
Merck Research Laboratories
10:45 Break
11:00 FDA Presentation Patricia Rohan, M.D., FDA
12 noon Lunch
4:30 p.m. Adjourn meeting