Background Analysis: US FDA Advisory Committees to Review Risk Evaluation and Mitigation Strategies for Extended-Release and Long-Acting Opioid Analgesics – May 3-4, 2016 (AADPAC-DSRM)
The US FDA has scheduled a joint meeting of the Anesthetic and Analgesic Drug Products and the Drug Safety and Risk Management Advisory Committees for Tuesday to Wednesday, May 3-4, 2016. The Committees will discuss results from assessments of the extended-release and long-acting (ER/LA) Opioid Analgesics Risk Evaluation and Mitigation Strategies (REMS). The Agency will seek comments as to whether the REMS with Elements to Assure Safe Use (ETASU) assures safe use, is not unduly burdensome to patient access to the drugs, and to the extent practicable, minimizes the burden to the healthcare delivery system.
see the SAC Tracker report