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U.S. Department of Health and Human Services

Advisory Committees

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Draft Agenda for the November 15, 2010 Meeting of the Science Board to the FDA

Bethesda Marriott, 5151 Pooks Hill Road, Bethesda, MD 20814

8:30 a.m.

Introductions
Barbara McNeil, M.D., Ph.D., Science Board Chair

8:40 a.m.

Commissioner's Report
Margaret Hamburg M.D., Commissioner of Food and Drugs

9:00 a.m.

Q&A and Discussion    

9:15 a.m.

Science at the FDA
Jesse Goodman, M.D., M.P.H., Chief Scientist and Deputy Commissioner for Science and Public Health, Office of the Chief Scientist, Office of the Commissioner, FDA

9:55 a.m.

Q&A and Discussion

10:15 a.m.

BREAK

10:30 a.m.

CFSAN evaluation and review of Subcommittee Final Review of Science at CFSAN
Donald Zink, Ph.D., Senior Science Advisor, CFSAN or Michael Landa, J.D., Acting Director, CFSAN

11:15 a.m.

Q&A and Discussion    

11:30 a.m.

Medical Countermeasures Initiative and Regulatory Science
Luciana Borio, M.D., Senior Advisor for Medicine and Public Health, Office of the Chief Scientist, Office of the Commissioner, FDA

11:45 a.m.

Q&A and Discussion

12:00 p.m.

Lunch (on your own)

1:00 p.m.

Open Public Hearing

2:00 pm

Discussion: Comparative Effectiveness Research Plan
Vicki Seyfert-Margolis, Ph.D., Senior Advisor for Science, Office of the Chief Scientist, Office of the Commissioner, FDA

2:45 p.m.

Q&A and Discussion

3:00 p.m.

Update: Subcommittee Review of Research at the Center for Drug Evaluation and Research (CDER), Pharmacovigilance Program
Garret Fitzgerald and Stephen Spielberg, co-chairs, Science Board Members
 

3:30 p.m.

Q&A and Discussion

3:40 p.m.

Comments from the Science Board Chair
Barbara McNeil, M.D., Ph.D., Science Board Chair

4:00 p.m.

Adjourn