FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Expert Committees to Consider REMS for Transmucosal Immediate-Release Fentanyl

July 12, 2018
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The FDA scheduled a joint meeting of its Anesthetic and Analgesic Drug Products and Drug Safety and Risk Management Advisory Committees on Aug. 3 to consider results from the transmucosal immediate-release fentanyl (TIRF) medicines’ risk evaluation and mitigation strategy approved in December 2011.

Under the REMS, healthcare providers who prescribe the medicines for outpatient use and the pharmacies that dispense them must be specially certified.

The FDA wants input from the committees on possible amendments to the TIRF REMS goals and requirements and the adequacy of the REMS assessments in determining whether goals are being met.

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