NOV 24-25 AADPAC

The US FDA has scheduled an Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) Meeting for Monday and Tuesday, November 24-25, 2014 to discuss the risk of serious neurologic adverse reactions associated with epidural steroid injections (ESI) administered to reduce inflammation for pain management. The committee will also consider the efficacy of ESI and the overall risk-benefit balance of injecting steroids in the epidural space to treat pain. These considerations will assist the Agency in discussions of possible regulatory options, including, but not limited to, changes to the product labeling.

See the SAC Tracker Report