FDA Education Blueprint for Prescriber Eduation for Extended-Release and Long-Acting Opioids
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Request for comment by July 10, 2017: Draft Revisions to the Food and Drug Administration Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioids
The FDA announced a the availablity of draft revisions to the “FDA Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioid Analgesics” (Blueprint). The Blueprint is part of the FDA-approved risk evaluation and mitigation strategy (REMS) for extended release (ER) and long-acting (LA) opioid analgesic medications (ER/LA Opioid Analgesics REMS). FDA is considering modifications to the existing Blueprint in light of recommendations from the May 2016 Advisory Committee meeting. The draft revisions to the Blueprint being made available pursuant to this notice would broaden the Blueprint to include information on pain management, including the principles of acute and chronic pain management; non-pharmacologic treatments for pain; and pharmacologic treatments for pain (both non-opioid analgesic and opioid analgesic). FDA intends to consider public input as it considers modifications to the ER/LA Opioid Analgesics REMS.To read the entire Federal Register Notice and to make comments electronically.