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

Executive Summary

FDA final guidance on MUsTs for topically applied ingredients for OTC drug monograph affirms draft, not incorporating changes pushed by industry. CHPA says FDA’s MUsT study published recently finding sunscreen actives penetrate skin to bloodstream at higher levels than previously believed demonstrates "value" of test method.

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FDA Sunscreen MUsT’s ‘Real World’ Applicability Under Debate, Which Could Hold Up Testing

Spaulding Clinical, which the FDA contracted for its sunscreen maximal usage trial published in May, is in discussions with a handful of sunscreen industry players about doing more MUsTs to fulfill data needs identified by the agency. Meanwhile, leading trade groups are interested in talking to the FDA about developing sunscreen study protocols that more accurately reflect real-world consumer usage.

Need Private Meeting For Sunscreen MUsT Details? Just Ask, FDA Says

"FDA meetings with an individual manufacturer regarding inclusion of ingredients in the monograph ... could have broad applicability, and hence are generally public," CDER says. But, "regulations permit any person to request a private meeting, and FDA will make reasonable efforts to accommodate such requests."

FDA 'May Hold Private Meetings' Offer Eases Sunscreen Monograph Tension

Proposed final sunscreen monograph published in February provided more clarity for TEA sponsors to engage with agency, but May publication of final guidance on MUsT for topically applied ingredients for OTC drug monograph could motivate TEA sponsors for sunscreen and other topical active ingredients to push their proposals forward.

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