Current Topics on Opioid REMS

FDA initiated a risk appraisal and mitigation strategy (REMS) for extended-release and long-acting (ER/LA) opioids that required companies marketing ER/LA opioids to provide a medication direct and make teaching available to prescribers. The training must be provided by accredited providers and cover all elements of the agency's Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioid Analgesics.

  • FDA Issues Guidance on REMS
  • Drug Safety and Risk Management Advisory Committee
  • Anesthetic and Analgesic Drug Products Advisory Committee

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