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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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OTC Antiseptic Industry Advancing Work To Show Germ-Killing Ingredients Are GRASE

Notwithstanding issues with contract testing labs and a lull in US FDA communication, the American Cleaning Institute is optimistic about progress to support GRASE decision-making for OTC topical antiseptic products, including pilot maximal usage trial (MUsT) studies and proposed investigations to see if antimicrobial soap reduces MRSA transmission in US military barracks.

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."

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