Children are Therapeutic Orphans

4/29/99


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Table of Contents

Children are Therapeutic Orphans

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The Problem

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Pediatric Labeling Benchmarks

AAP - 1977 Committee on Drugs

Labeling Requirement[44FR, 6/26/79]

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1992 Proposed Regulations

Pediatric Rule of 1994

Pediatric Rule of 1994

1994 RESPONSE

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History of Pediatric Regulations/Legislation

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2 Major Approaches

Key Elements

An Act 105th Congress

FDAMA Incentive

FDAMA Process

FDAMA Process

FDAMA Process

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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

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Final Rule vs. FDAMA

Final Rule vs. FDAMA

Final Rule vs. FDAMA

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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

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To Find out More

Author: CDER User