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U.S. Department of Health and Human Services

For Industry

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Agenda, PDUFA Public Meeting February 16, 2007

8:00-8:45 am  Registration

9:00 am  Welcome  
Mark Barnett, M.P.H., FDA Moderator

9:05 am  Opening Remarks
Andrew C. von Eschenbach, M.D.
U.S. Food and Drug Administration Commissioner

9:15-9:30 am   Funding Human Drug Review: Resources for Drugs and Biologics
Janet Woodcock, M.D., Chief Medical Officer, FDA

9:30-9:45 am  Background and History of PDUFA Program
Steven Galson, M.D., M.P.H., Director, FDA CDER

9:45-10:30 am

FDA Proposed Recommendations for PDUFA IV

Sound Financial Footing 
Theresa Mullin, Ph.D., Assistant Commissioner for Planning
Pre-market Review 

John K. Jenkins, M.D., Director, Office of New Drugs, FDA CDER
Information Management

Malcolm Bertoni, M.S., Director, Planning Staff, FDA Office of Planning


10:30-10:45 am Break (15 minutes)    

10:45-11:30 am Post-market Safety
Deborah Henderson, Director, Office of Executive Programs, FDA CDER
Advisory Review of Direct-to-Consumer Television Advertising
Jane Axelrad, J.D., Associate Director for Policy, FDA CDER

11:30-12:30 pm  Lunch

12:30-4:00 pm 

Public Comment on FDA Proposed Recommendations for PDUFA IV

Patient Perspectives
Consumer Perspectives
Health Professional Perspectives
Industry Perspectives
Other Perspectives


4:00-4:15 pm Break

4:15-5:00 pm General Public Comments

5:00 pm   Closing Comments
Theresa Mullin, Ph.D., Assistant Commissioner for Planning