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GUIDANCE DOCUMENT

Maximal Usage Trials for Topically Applied Active Ingredients Being Considered for Inclusion in an Over-The -Counter Monograph: Study Elements and Considerations May 2019

Final

Maximal Usage Trials for Topically Applied Active Ingredients Being Considered for Inclusion in an Over-The -Counter Monograph: Study Elements and Considerations

Docket Number:
2019-09692
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

This guidance provides recommendations for the conduct of in vivo absorption trials for topically applied active ingredients that are under consideration for inclusion in an over-the-counter (OTC) drug monograph. A Maximal Usage Trial (MUsT) is a standard approach to assess the in vivo bioavailability of topical drug products intended for local therapeutic effects. , The methodology described in this guidance adapts MUsT principles for active ingredients being considered for inclusion in an over-the-counter (OTC) monograph. Because information from a MUsT can help identify the potential for systemic exposure to a topically applied active ingredient, such information can help inform an FDA determination of whether additional safety data are needed to support a finding that a topical OTC drug containing that active ingredient is generally recognized as safe and effective (GRASE) for its intended use.

This guidance outlines the FDA’s recommendations for designing and conducting a MUsT for this purpose, including critical study elements, data analysis, and considerations for special topic areas (e.g., pediatrics, geriatrics). This guidance also encourages study sponsors to seek feedback from the FDA on their overall approach and the design of a particular study.


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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: 2019-09692.