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FDA’s MUsT Draft Guidance Extends Challenge To Wider OTC Drug Industry

 
• By Ryan Nelson

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maximal usage trials have been the bane of OTC sunscreen and antimicrobial drug ingredient sponsors of late, but new draft guidance from the agency signals that MUsTs will be expected generally from companies looking to add topical ingredients to OTC drug monographs.

female scientist working with microscope

Newly released draft guidance from FDA underscores the agency’s increasing reliance on maximal usage trials (MUsTs) to support topical ingredients’ inclusion in OTC drug monographs.

The document could have more companies contemplating new drug approval pathways as an alternative to generally recognized as safe and effective (GRASE) review, a process in which stakeholder confidence

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