Table of Contents
Update onPediatric Initiatives
Exclusivity Process
Exclusivity Process
Moietieswith Exclusivity Granted
PPSRs by Division
PPSRs by Division
Studies Requested
Efficacy Studies
Efficacy Studies (contd)
Efficacy Trials (contd)
Efficacy Trials (contd)
Template Written Requests
Issues
Other initiatives
Other initiatives
Other initiatives
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Author: Murray M. Lumpkin, M.D., Deputy Center Director, Center for Drug Evaluation and Research
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