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8:00-8:45 am |
Registration |
9:00 am |
Welcome |
9:05 am |
Opening Remarks |
9:15-9:30 am |
Funding Human Drug Review: Resources for Drugs and
Biologics |
9:30-9:45 am |
Background and History of PDUFA Program |
9:45-10:30 am |
FDA Proposed Recommendations for PDUFA IV Sound Financial Footing |
10:30-10:45 am |
Break (15 minutes)
|
10:45-11:30 am |
Post-market Safety |
11:30-12:30 pm |
Lunch |
12:30-4:00 pm |
Public Comment on FDA Proposed Recommendations for PDUFA IV Patient Perspectives |
4:00-4:15 pm |
Break |
4:15-5:00 pm |
General Public Comments |
5:00 pm |
Closing Comments |