Oncology Pediatric Initiatives

4/13/00


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Table of Contents

Oncology Pediatric Initiatives

Food and Drug Modernization Act of 1997- An incentive Program

Pediatric Rule of 1998- A Mandate

Comparison of FDAMA vs. 1998 Rule

Pediatric Exclusivity

FDA experience with FDAMA incentive

Pediatric Development Plan

Pediatric Development Plan

Pediatric Development Plan

Possible Outcomes

Results of Completion of a Pediatric Development Plan