SEP 16 PEDAC

Results Wire: US FDA Advisory Committee Reviews the Pediatric Safety of 18 Products Under BPCA/PREA/PMDSIA – SEP 16, 2015 (PEDAC)

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, a majority of the Committee members unanimously concurred with FDA’s proposal to continue routine surveillance.

See the SAC Tracker report