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Impact of Pediatric Initiatives June 15, 2004
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Impact of Pediatric Initiatives
Overview
Acronyms
Pediatric Benchmarks
History of Pediatric Regulations/Legislation
2002 Best Pharmaceuticals for Children Act (BPCA)
Best Pharmaceuticals for Children Act (cont.)
Goal
BPCA- Provisions
Written Request (WR)
FDA On-Patent Drug Exclusivity Process
BPCA Off-Patent Drugs
BPCA
FDA/NIH Partnership
Development of the List
2003 List of Drugs for Which Pediatric Studies Are Needed
Update of the List
Process for the Study of Off-Patent Drugs
2003 Pediatric Research Equity Act (PREA)
Pediatric Research Equity Act (cont.)
PREA : Meaningful Therapeutic Benefit
PREA: Deferrals
PREA: Deferrals (cont.)
PREA: Waiver
PREA: Waiver (cont.)
Results
RESULTS May 4, 2004
Exclusivity: On-Patent Summary of Important Findings
Growth and Development
Cognition and Behavior
Progress: Product Labeling with Significant Changes for Dosing or Risk
Progress: Identification of a Safety and Effectiveness Issue
Lessons Learned
What Have We Learned
ONGOING LESSONS LEARNED
Ethical Issues
General Principles ICH E-11
FDA Home Page (Link to Peds Page)
Summaries of Pediatric Reviews on the Web
Examples of Important Findings from Summaries Available on FDA Pediatrics Web (N=19)
Presented: June 15, 2004 Drug Information Association Annual Meeting
Download presentation source (PowerPoint format)
Back to Top Back to Pediatric Drug Development
Date created: June 15, 2004
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