The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Maximal Usage Trials for Topical Active Ingredients Being Considered for Inclusion in an Over-the-Counter Monograph: Study Elements and Considerations.'' This draft guidance addresses FDA's current thinking on the conduct of in vivo absorption trials for topical active ingredients that are under consideration for inclusion in an over-the-counter (OTC) monograph.
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Maximal Usage Trials for Topical Active Ingredients Being Considered for Inclusion in an Over-the-Counter Monograph: Study Elements and Considerations; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Maximal Usage Trials for Topical Active Ingredients B...
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83 FR 23918
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“Maximal Usage Trials for Topical Active Ingredients Being Considered for Inclusion in an Over-the-Counter Monograph: Study Elements and Considerations; Draft Guidance for Industry; Availability,” thefederalregister.org (May 23, 2018), https://thefederalregister.org/documents/2018-10993/maximal-usage-trials-for-topical-active-ingredients-being-considered-for-inclusion-in-an-over-the-counter-monograph-stud.