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

 
• By Eileen Francis

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.

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Spaulding Clinical Research, LLC, stands at ready to conduct maximal usage trials (MUsTs) for interested sunscreen industry players, similar to the one it did for the US Food and Drug Administration, and says it has been contacted by a number of companies already.

“We anticipate more needing to do so,” the West Bend, Wisc.-based clinical research organization notes on its website.

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