The Pediatric Advisory Committee will meet to discuss pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act.

In addition, from 8:30 to 9:30 a.m. (US EST), FDA will provide information on the 2-day joint meeting of the Pediatric Advisory Committee, the Anesthetic and Analgesic Drug Products Advisory Committee, and the Drug Safety and Risk Management Advisory Committees on September 15 and 16, 2016. This Committees will discuss appropriate pediatric development plans for prescription opioid drugs.