‘Vast Majority’ Of Antibac Soaps Need Reformulation Under FDA Final Rule
Executive Summary
FDA says the “vast majority” of roughly 2,100 consumer antibacterial soaps on the market contain at least one of 19 antimicrobial ingredients banned from OTC use under new final rule. Industry, which suggests the agency is overstating the rule’s impact, is focused on delivering supporting data for three active ingredients still pending before FDA for GRASE use in the category.
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Systemic Exposure Data A MUsT For OTC Monograph Sunscreens, Other Topical Drugs In FDA Draft Guidance
Challenges posed by FDA-advised maximal usage trials have been the bane of OTC sunscreen and antimicrobial drug ingredient sponsors recently, but a draft guidance from the agency signals that those trials will be expected generally from companies looking to add topical ingredients to OTC drug monographs. CDER details its expectations for studies of ingredients’ absorption potential to inform systemic exposure and overall safety and efficacy conclusions.
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