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Other expedited pathways like fast track, priority review or breakthrough could be appropriate, according to new draft guidance.
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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.
Commissioner Robert Califf said the new plan should be released in August and include prongs to continue fighting the ongoing prescription opioid epidemic, as well as confront a new synthetic fentanyl and methamphetamine problem.