Table of Contents
Children are Therapeutic Orphans
PPT Slide
The Problem
PPT Slide
Pediatric Labeling Benchmarks
AAP - 1977 Committee on Drugs
Labeling Requirement[44FR, 6/26/79]
PPT Slide
1992 Proposed Regulations
Pediatric Rule of 1994
Pediatric Rule of 1994
1994 RESPONSE
PPT Slide
PPT Slide
History of Pediatric Regulations/Legislation
PPT Slide
2 Major Approaches
Key Elements
An Act 105th Congress
FDAMA Incentive
FDAMA Process
FDAMA Process
FDAMA Process
PPT Slide
Approved Drug Products to which FDA has issued a Written Request for Pediatric Studies
Approved Drug Products to which FDA has issued a Written Request for Pediatric Studies
Approved Drug Products to which FDA has issued a Written Request for Pediatric Studies
Written Request Types of Studies
“Other” Studies
Ages Included in Written Requests
AGES: OTHER
Exclusivity Summary
FDAMA Reporting Activities
2 Major Approaches
1998 Final Rule
Final Rule Now?
Final Rule Now?
Scope
Marketed Drugs
New Drugs
“Meaningful Therapeutic Benefit”
“Substantial Use”
Waiver Criteria
Deferral Criteria
Final Rule Effective: April 1, 1999
Implementation and Integration
Integration of Pediatric Rule
Communication of Pediatric Study Requirements
Interaction of FDAMA and Rule
Interaction of FDAMA and Rule
Interaction of FDAMA and Rule
PPT Slide
Final Rule vs. FDAMA
Final Rule vs. FDAMA
Final Rule vs. FDAMA
PPT Slide
Pediatric Advisory Subcommittee
Sample Case #1
Sample Case #1
Sample Case #1
Sample Case #2
Sample Case #2
Sample Case #3
Sample Case #3
Sample Case #4
Sample Case #4
Sample Case #5
Sample Case #5
Future Considerations
Issues for the Pediatric Advisory Subcommittee
Provide Annual Oversight of the Implementation of the Rule
Discuss Ethical Issues Raised by Clinical Trials in Pediatric Patients
Review Trial Designs and Data Analysis
Review Need for Additional Therapeutic Options
Recommend Marketed Products to be Studied
Provide Oversight on Progress of Studies
Development of Reporting Requirements
Data Collected by Pediatric Tracking System
Data Collected by Pediatric Tracking System (cont’d)
Labeling
PPT Slide
PPT Slide
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