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
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