Non-Opioid Pain Treatments Likely Not Eligible For Accelerated Approval, US FDA Says
Other expedited pathways like fast track, priority review or breakthrough could be appropriate, according to new draft guidance.
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Although a new FDA guidance recommends difference in pain scores as the primary efficacy endpoint for evaluation of postoperative analgesic effect, data on outcomes such as reduction in hospitalization and deaths from opioid abuse would be valuable and could provide a basis for inclusion in labeling; guidance is part of broader agency effort to reduce opioid use.
Petition Suggests US FDA Use Monograph Authority To Limit Indications For External Analgesic Patches
Citizen petition suggests safety evidence lacking to affirm GRASE for some indications for patch, plaster or poultice dosage forms of OTC external analgesics. CHPA counters that petition inaccurately compares common OTC products with Rx drugs.
US FDA explored whether existing law allowed for the higher standard, but determined new authority granted by Congress was necessary.