Results Wire: US FDA Advisory Committee Reviews the Pediatric Safety of Products and Hears About Upcoming Joint Meeting with the AADPAC and DSRM – APR 12, 2016 (PEDAC)
On Tuesday, April 12, 2016, the Pediatric Advisory Committee (PEDAC) discussed 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 12 of the products that were reviewed, the Committee unanimously concurred with FDA’s proposal to continue routine surveillance. For the other products, the Committee did not have a unanimous vote or, in some cases, added or modified FDA’s recommendations.
See the SAC Tracker report