The US FDA has posted FDA Briefing Materials, for the joint meeting of the Pediatric Advisory Committee (PEDAC), the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC), and the Drug Safety and Risk Management (DSRM) Advisory Committees for Thursday and Friday, September 15 to 16, 2016. The Committees will discuss the appropriate development plans for establishing the safety and efficacy of prescription opioid analgesics for pediatric patients, including obtaining pharmacokinetic data and the use of extrapolation.

See the SAC Tracker report