On May 3 and 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 the Committees’ 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 FDA Announcement