Anesthetic and Analgesic Drug Products and the Drug Safety and Risk Management Advisory Committees


On Tuesday to Wednesday, May 3-4, 2016, members of the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) and the Drug Safety and Risk Management Advisory Committee (DSRM) voted unanimously in favor of modifying the Risk Evaluation and Mitigation Strategies (REMS) for extended-release and long-acting (ER/LA) opioids. All thirty members voted to modify the REMS. No members voted to continue the REMS without modifications or to eliminate the REMS.

See the FDA Announcement