Because of how many acronyms they each have mastered!

5/3/99


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Table of Contents

Because of how many acronyms they each have mastered!

PPT Slide

FDA’s Pediatric Team

PhRMA’s Commitment to Pediatric Drug Development

Identification of Therapeutic Areas in Need of Drugs for Children

International Conference on Harmonization (ICH)

Resolving the Problems Posed by Multi-source Products

Cross Labeling of “Me Too Drugs”

FDA’s Current Processing of Selected Pediatric Issues

PhRMA Concerns:

PhRMA Concerns:

PhRMA Concerns:

PhRMA’s Concerns:

Need for FDA to Promptly Issue a Draft Guidance (which may have already started)

PhRMA Participation in Subcommittee’s Work

Clinical Trials

Clinical Trials

Clinical Trials

Clinical Trials

Author: Tim Tener