Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s continued, careful oversight of the REMS associated with transmucosal immediate-release fentanyl products
On Aug. 3, the U.S. Food and Drug Administration will be hosting a public advisory committee meeting to review data from the most recent assessment of the Risk Evaluation and Mitigation Strategy (REMS) with Elements to Assure Safe Use (ETASU) for transmucosal immediate-release fentanyl (TIRF) products. The FDA will be asking the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee to discuss the findings from the assessments conducted by manufacturers of these products, as well as additional data about their use patterns and adverse events. Asking the FDA’s advisory committees to take a closer look at this opioid-related REMS reflects our commitment to further evaluating this critical program and making sure we’re providing transparency around its effectiveness and whether any modifications may be necessary. These TIRF products are medically important but also pose serious risks. We’re seeking the advice of outside experts on the effectiveness of the REMS and whether changes to the REMS might be necessary.
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