External Analgesic Alternate Dosage Forms Supported By Recent Data – CHPA
This article was originally published in The Tan Sheet
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
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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.
FDA is proposing to clarify the tentative final monograph for OTC external analgesic drug products to exclude topical patch, plaster and poultice dosage forms, according to a Jan. 17 Federal Register notice
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