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The agency issued guidance on over-the-counter topical drug products that address maximal usage trials.
FDA issued guidance regarding over-the-counter (OTC) topical drug products in May 2018. One draft guidance provides recommendations on how to conduct in vivo absorption trials for topical active ingredients that are under consideration for inclusion in an OTC monograph, specifically the design of Maximal Usage Trials (MUsT) studies.
The guidance describes the methodology used to adapt MUsT principles for active ingredients. According to FDA, information from a MUsT can help identify the potential for systemic exposure to a topically applied active ingredient, which can help the agency determine “if additional safety data are needed to support a finding that an OTC drug containing that active ingredient is generally recognized as safe and effective (GRASE) for its intended use.” Outlined in the guidance are FDA’s recommendations for designing and conducting a MUsT, including critical study elements, data analysis, and considerations for special topic areas such as pediatrics.
“At the FDA, we’ve been working to better understand the absorption and safety profile of topical OTC products, such as sunscreens and topical antiseptics. We are particularly interested in learning how these products affect vulnerable populations, such as children, the elderly, and pregnant and breastfeeding women,” said Theresa M. Michele, MD, Director of the Division of Nonprescription Drug Products, Office of New Drugs, at the FDA’s Center for Drug Evaluation and Research, in an FDAVoice blog post. “Absorption studies have contributed significantly to the FDA’s knowledge of the safety of topical prescription products. Applying a similar level of safety research to active ingredients being considered for inclusion in an OTC monograph to that which currently exists for prescription products can help the FDA determine whether these ingredients should be included in OTC products marketed without approved applications.”