Best Pharmaceuticals for Children Act: an FDA Implementation Perspective

3/27/2003

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Table of Contents Best Pharmaceuticals for Children Act: an FDA Implementation Perspective Objectives Best Pharmaceuticals for Children Act Best Pharmaceuticals for Children Act Other BPCA Highlights BPCA On Patent Drugs Process for the Study of On-Patent Drugs FDA On-Patent Drug Exclusivity Process BPCA Off-Patent Drugs An FDA/ NIH Partnership Process for the Study of Off-Patent Drugs FDA/NIH Off-Patent Drug Process FDA/NIH Partnership 2003 List of Drugs for Which Pediatric Studies Are Needed FDA/NIH Partnership Goal What is the Role of Division Pediatric Drug Development? What is the Role of Division Pediatric Drug Development? Division of Pediatric Drug Development - who are we? Pediatrics Structure Office of Pediatric Therapeutics: a BPCA Provision Office of Pediatric Therapeutics: a BPCA Provision Office of Pediatric Therapeutics Efficiencies To Learn More:

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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FDA/Center for Drug Evaluation and Research
Last Updated: April 10, 2003
Originator: OCTAP/DPDD
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