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Pediatric Advisory Committee

This article was originally published in The Tan Sheet

Executive Summary

New FDA committee will "provide advice and make recommendations to the commissioner...on matters relating to pediatric therapeutics, pediatric research and any other matter involving pediatrics for which the [FDA] has regulatory responsibility," the agency announces in a final rule slated for publication in the Aug. 2 Federal Register. The 12 voting members will bring experience in pediatric research, subspecialties, statistics and/or bioethics, including a patient organization rep and a "technically qualified member" with consumer interests. FDA also announces the creation of a pediatric ethics subcommittee and requests nominations in separate same-day notices. Formation of the panel is in accordance with the Pediatric Research & Equity Act (1"The Tan Sheet" Dec. 1, 2003, In Brief)...
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