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Description
In the March 28, 2007, Federal Register, NIH provided notice of the Priority List of Drugs for Which Pediatric Studies Are Needed. NIH develops the list in consultation with FDA and pediatric experts, as mandated by the Best Pharmaceuticals for Children Act (BPCA). These are drugs that are most in need of study for use by children to ensure their safety and efficacy. NIH updates the list at least annually.
BPCA stipulates that in developing the list, NIH shall consider for each drug on the list: (1) The availability of information concerning the safe and effective use of the drug in the pediatric population; (2) whether additional information is needed; (3) whether new pediatric studies concerning the drug may produce health benefits in the pediatric population; and (4) whether reformulation of the drug is... |
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