FDA doubles down on MUsT studies for sunscreens and issues final guidance on absorption studies that will likely be needed for continued marketing

On 10 May 2019 the U.S. Food and Drug Administration (FDA) published a notice of availability for a final guidance document on Maximal Usage Trials (MUsT studies) for topically applied active ingredients being considered for over-the-counter (OTC) drug monographs, including sunscreens.

As FDA has previously explained, the guidance states that MUsT studies can identify the potential for the systemic exposure for a topically applied active ingredient. FDA believes that this information is necessary to determine whether additional safety studies are needed to support a finding that the ingredient is generally recognized as safe and effective (GRASE) for its intended use.

Read More: FDA doubles down on MUsT studies for sunscreens and issues final guidance on absorption studies that will likely be needed for continued marketing


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