Background Analysis: US FDA Advisory Committee to Review Drugs Under PREA/BPCA/PMDSIA and Discuss Upcoming Joint Meeting with the AADPAC and DSRM – APR 12, 2016

The US FDA has scheduled a meeting of the Pediatric Advisory Committee (PEDAC) for Tuesday, April 12, 2016.  The Committee will discuss pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act (BPCA), the Pediatric Research Equity Act (PREA), and the Pediatric Medical Device Safety and Improvement Act (PMDSIA). In addition, FDA will provide information on the 2-day joint meeting of the PEDAC, the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC), and the Drug Safety and Risk Management (DSRM) Advisory Committee on September 15 and 16, 2016.

See the SAC Tracker report