• Regulatory NewsRegulatory News

    FDA Takes First Steps to Modify TIRF REMS Program

    The Risk Evaluation and Mitigation Strategy (REMS) for transmucosal immediate-release fentanyl (TIRF) medicines is being strengthened by the US Food and Drug Administration (FDA) to better ensure the appropriate patients are receiving these opioids, the agency announced Wednesday. Following an advisory committee meeting on the REMS last August, as well a recently published study in JAMA that found that “thousands of patients receiving TIRFs were opioid-nontolerant...
  • Regulatory NewsRegulatory News

    Study Evaluates How an Opioid’s REMS Did Not Work as Intended

    Research published in JAMA on Tuesday details how a US Food and Drug Administration (FDA) class-wide Risk Evaluation and Mitigation Strategy (REMS) did not prevent the inappropriate prescribing of transmucosal immediate-release fentanyls (TIRFs), which were approved solely for breakthrough cancer pain in opioid-tolerant patients. The study, conducted by researchers from the Johns Hopkins Bloomberg School of Public Health and the Center for Science in the Public Intere...