Ethical Issue: Participation of Normal Healthy Pediatric Subjects in Clinical Trials

12/9/99


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Table of Contents

Ethical Issue: Participation of Normal Healthy Pediatric Subjects in Clinical Trials

Today’s Process

History of Pediatric Regulations/Legislation

Pediatric Rule: Update

Examples of Waivers: Partial or Complete

FDAMA Activity As of October 1, 1999

Types of Studies Requested As of October 1, 1999

Estimated Number of Children

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Conclusion: #1

Conclusion: #2

Conclusion: #3

Conclusion: #4

Conclusion: #5

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$ Economic Issues $

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The Third Chimpanzee: The Evolution and Future of the Human Animal (Jared Diamond)

Arthur Wichmann - 1912

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Goal

Goal

To Find out More

Author: CDER User