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JANUARY 14, 2021

FDA Bolsters Opioid Tolerance Provisions in REMS Program for Transmucosal Immediate-Release Fentanyl Products

The FDA announced plans to strengthen its Risk Evaluation and Mitigation Strategies (REMS) program for transmucosal immediate-release fentanyl (TIRF) products “to help ensure that the benefits of these drugs continue to outweigh the risks,” according to a statement by an agency official.