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.
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Other expedited pathways like fast track, priority review or breakthrough could be appropriate, according to new draft guidance.
Authorization was a long time coming for FDA to reform OTC monograph program and streamline process to change formulations, indications or labeling for large majority of drugs available nonprescription. As program is overhauled, monograph updates may seem to be coming just as slowly.
CHPA requests that FDA withdraw its proposal to exclude patches, plasters and poultices from the OTC external analgesics tentative final monograph in Oct. 15 comments