Fruits of the Pediatric Initiatives:
a CDER Update

3/27/2003

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Table of Contents Fruits of the Pediatric Initiatives: a CDER Update Overview Best Pharmaceuticals for Children Act Pediatric Exclusivity "The Carrot" Pediatric Exclusivity Studies Breakdown for Issued WRs Ethical Issues What We Have Accomplished ? Labeled Products Labeled Products with Significant New Information Labeled Products with Significant New Information Labeled Products with Significant New Information Labeled Products with Significant New Information Labeled Products with Significant New Information Labeled Products with Significant New Information Pediatric Rule Update Pediatric Rule (Apr 99 – Dec 02) Pediatric Rule What Have We Learned? To Contact Us:

Author:  Debra Birenbaum, M.D.  Lead Medical Officer  Division of Pediatric Drug Development Office of Counter-Terrorism and Pediatric Drug Development (OCTAP), Center for Drug Evaluation and Research Food and Drug Administration Download presentation source [PowerPoint format]

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Last Updated: April 10, 2003
Originator: OCTAP/DPDD
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