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CDER's Experience: What we have learned from The Pediatric Initiative
General Principles
Pediatric Drug Development
FDAMA Process (1997)
Pediatric Exclusivity Statistics as of 1/01/02
Studies Breakdown Report for Issued Written Requests as of 1/1/2002
Response to Pediatric Exclusivity as of January 30, 2002
Health Impact of New Labels as of 1/30/02
Product Labeling with Significant Changes for Dosing or Risk
Product Labeling with Significant Changes for Dosing or Risk (continued)
Safety & Effectiveness Issues
Diseases (Conditions) for which Product Labeling Extended Age and Safety
Pediatric Rule
The Pediatric (Final) Rule
Completed Studies Waiver or Deferral
Pediatric Rule Update April 1999 through December 2001
Final Rule vs. FDAMA
What have we learned?
Final Rule, FDAMA and The Best Pharmaceuticals for Children Act
Additional Information
Pediatric age groups
Product Labeling that Extends Age and Safety Profile
Product Labeling that Extends Age and Safety Profile (continued)
Author:William Rodriguez, M.D.Office of Pediatric Drug Development and Program Initiatives Center for Drug Evaluation and ResearchFood and Drug Administration
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FDA/Center for Drug Evaluation and Research Last Updated: July 18, 2002 Originator: OCTAP/DPDD HTML by NM
