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Pediatric Advisory Committee

On Wednesday, September 16, 2015, the Pediatric Advisory Committee (PEDAC) discussed 18 pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act, the Pediatric Research Equity Act, and the Pediatric Medical Device Safety and Improvement Act of 2007. For all of the products that were reviewed, the a majority of the Committee members concurred with FDA’s proposal to continue routine surveillance.