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FDA’s MUsT Draft Guidance Extends Challenge To Wider OTC Drug Industry

This article was originally published in The Rose Sheet

Executive Summary

It’s known that challenges posed by FDA-advised maximal usage trials have been the bane of OTC sunscreen and antimicrobial drug ingredient sponsors of late, but new draft guidance from the agency signals that MUsTs will be expected generally from companies looking to add topical ingredients to OTC drug monographs.

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FDA Final MUsT Guidance For Topical OTCs Bolstered By Agency's Recent Study Results

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