OCT 5 AADPAC-DSRM

The US FDA has scheduled a meeting of the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) and the Drug Safety and Risk Management (DSRM) Advisory Committee for Wednesday, October 5, 2016. The Committees will be asked to discuss the most appropriate dose or doses of naloxone products to reverse the effects of life-threatening opioid overdose in all ages, and the role of having multiple doses available in this setting. The Committees will also be asked to discuss the criteria that prescribers will use to select the most appropriate dose in advance of an opioid overdose event and the labeling to inform this decision, if multiple doses are available.

See the SAC Tracker report