Table of Contents
1999 Pediatric Initiatives
The Problem
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Pediatric Labeling Benchmarks
AAP - 1977 Committee on Drugs
Labeling Requirement[44FR, 6/26/79]
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Pediatric Rule of 1994
Final RuleTypes of Studies
1994 RESPONSE
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History of Pediatric Regulations/Legislation
2 Major Approaches
Key Elements
FDAMA Incentive
FDAMAProcess
FDAMA Process
FDAMAProcess
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TOTAL PPSR Actions
Number of Pediatric PatientsAs of May 31, 1999
Exclusivity Summary
2 Major Approaches
1998 Final Rule
Scope
Marketed Drugs - Pediatric Studies Required
New Drugs
Meaningful Therapeutic Benefit
Substantial Use
Waiver Criteria
Deferral Criteria
Final Rule Effective: April 1, 1999
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Final Rule vs. FDAMA
Final Rule vs. FDAMA
Final Rule vs. FDAMA
Implementation and Integration
Integration of Pediatric Rule
Communication of Pediatric Study Requirements
Interaction of FDAMA and Rule
Interaction of FDAMA and Rule
Pediatric Advisory Subcommittee
Issues for the Pediatric Advisory Subcommittee
Labeling
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Author: Dianne Murphy, M.D.
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