Center for Drug Evaluation and Research, U.S. Food and Drug Administration

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Update on Pediatric Initiatives

20 October 1999

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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

Other initiatives

Other initiatives

Other initiatives

Web Site Information

Author: Murray M. Lumpkin, M.D., Deputy Center Director, Center for Drug Evaluation and Research

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