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 Rule Types of Studies
1994 RESPONSE
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History of Pediatric Regulations/Legislation
2 Major Approaches
Key Elements
FDAMA Incentive
FDAMA Process
FDAMA Process
FDAMA Process
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TOTAL PPSR Actions
Number of Pediatric Patients As 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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To Find out More |
Author: Dianne Murphy, M.D.
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