The US FDA has posted details, including company and FDA Briefing Materials, for the Tuesday to Wednesday, May 3-4, 2016 joint meeting of the Anesthetic and Analgesic Drug Products (AADPAC) and the Drug Safety and Risk Management (DSRM) Advisory Committees. 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.
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