Sets forth procedures for making labeling changes for already marketed drugs, if so indicated by such studies.
Eliminates the user fee waiver for pediatric supplements to a human drug application.
Sets forth requirements for the additional six-month exclusivity period for new or already-marketed pediatric drugs.
Amends Title IV of the Public Health Service Act to direct the Secretary to establish the Foundation for Pediatric Research to support research on drugs lacking exclusivity for which pediatric studies are needed.
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.
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.