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Establishes a Food and Drug Administration (FDA) contract process for related labeling changes.
Amends the Federal Food, Drug, and Cosmetic Act to: (1) eliminate the user fee waiver for pediatric supplements to a human drug application; (2) provide priority status for pediatric supplements; (3) include neonates within the definition of pediatric studies; (4) provide for dissemination of pediatric supplement information; and (5) set forth requirements for the additional six-month exclusivity period for new or already-marketed pediatric drugs.
Directs the Secretary to establish an Office of Pediatric Therapeutics within the Office of the Commissioner of Food and Drugs, which shall coordinate all FDA pediatric activities.
Includes within the purposes and activities of the Foundation for the National Institutes of Health the collection of funds for pediatric pharmacological research.
Directs the Secretary to contract with the Institute of Medicine to review Federal regulations, reports, and support for research involving children, with particular attention to issues of compensation, informed consent, and risk/ benefits assessments in terms of research versus therapeutic treatment.
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