2022-23018: In Vitro Permeation Test Studies for Topical Products Submitted in Abbreviated New Drug Applications; Draft Guidance for Industry; Availability
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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "In Vitro Permeation Test Studies for Topical Products Submitted in ANDAs." This draft guidance document provides recommendations for in vitro permeation test (IVPT) studies for locally acting liquid-based and/or other semisolid topical products. This draft guidance is intended to assist applicants who are submitting abbreviated new drug applications (ANDAs) for such products by providing recommendations for IVPT studies, which can be used to support a demonstration that two topical products are bioequivalent.
The agency’s own summary, as published.
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