Federal Register #FDA-2022-D-2170

FDA Final Guidance on In Vivo Bioequivalence for Topical Dermatologic Corticosteroids

This opportunity is an informational release from the Food and Drug Administration (FDA) regarding final guidance for industry on in vivo bioequivalence for topical dermatologic corticosteroids. - Government Buyer: - Department of Health and Human Services (HHS) - Food and Drug Administration (FDA) - No OEMs or vendors are specified, as this is a regulatory guidance document for industry applicants - No products or services are being procured or awarded - Key Details: - Guidance is for applicants submitting abbreviated new drug applications (ANDAs) for topical dermatologic corticosteroids - Covers all potency groups of these products - Recommends an in vivo pharmacodynamic approach to demonstrate bioequivalence - Includes pilot dose duration vasoconstrictor response and pivotal vasoconstrictor studies - Finalizes and replaces previous draft and 1995 guidance - No procurement action is being taken; this is a regulatory and informational notice only

Description

The Food and Drug Administration (FDA) announces the availability of a final guidance for industry titled "Topical Dermatologic Corticosteroids: In Vivo Bioequivalence." This guidance provides recommendations for applicants submitting abbreviated new drug applications (ANDAs) for topical dermatologic corticosteroids of all potency groups. It describes an in vivo pharmacodynamic approach to demonstrate bioequivalence, including pilot dose duration vasoconstrictor response and pivotal vasoconstrictor studies. The guidance finalizes the draft issued in 2022 and replaces the guidance issued in 1995.

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