In Vitro Release Test Studies for Topical Products Submitted in Abbreviated New Drug Applications; Draft Guidance for Industry; Availability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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "In Vitro Release Test Studies for Topical Products Submitted in ANDAs." This draft guidance provides recommendations for in vitro release test (IVRT) studies for locally acting liquid-based and/or other semisolid topical products. This draft guidance is intended to assist applicants who are submitting abbreviated new drug applications (ANDAs) for such products, by providing recommendations for IVRT studies,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