Background Analysis: US FDA Joint Advisory Committee to Review Development Plans for Opioid Use in Pediatric Patients – SEP 15-16, 2016 (PEDAC-AADPAC-DSRM)

The US FDA has scheduled a 2-day 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 Committee for Thursday and Friday, September 15 to 16, 2016. The purpose of this meeting is to 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