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Title slide
Overview
Pediatric Rule
Progress: Industry Response and Health Impact of 1997 FDAMA as of June 2002
Progress: Studies Requested as of June 2002 (1997 FDAMA)
Ethical Issues
Progress: Health Impact of 1997 FDAMA
Progress: Products with Labeling Changes as of June 2002
Progress: Products with Labeling Changes as of June 2002 (continued)
Progress: Product Labeling with Significant Changes for Dosing or Risk
Progress: Identification of a Safety and Effectiveness Issue
Progress: Pediatric Rule Update April 1999 - March 2001
Progress: Pediatric Rule Update April 1999 - December 2001
1997 FDAMA Initiative Issues
Report to Congress on Impact of FDAMA
New Legislation
To Find Out More
Author: Debra Birenbaum, M.D. Lead Medical Officer Division of Pediatric Drug Development
Office of Counterterrorism and Pediatric Drug Development (OCTAP) Center for Drug Evaluation and Research Food and Drug Administration
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FDA/Center for Drug Evaluation and Research Last Updated: July 9, 2002 Originator: OD/OCTAP/DPDD HTML by MAU
