CENTER FOR DRUG EVALUATION AND RESEARCH

DIVISION of
DRUG INFORMATION

Your source for the latest drug information. Know the moment it happens.

​

FDA publishes the final guidance for industry, “Topical Dermatologic Corticosteroids: In Vivo Bioequivalence”

On July 13, 2026, FDA published the final guidance for industry titled “Topical Dermatologic Corticosteroids: In Vivo Bioequivalence.” This guidance is intended to assist applicants who submit abbreviated new drug applications (ANDAs) for topical dermatologic corticosteroid products (topical corticosteroids) and describes recommendations for in vivo studies to demonstrate the bioequivalence (BE) of topical corticosteroids.

This guidance provides recommendations for the study design, method qualification, data analysis, and data reporting for the pilot dose-duration vasoconstrictor response study and pivotal vasoconstrictor BE study used to demonstrate BE of topical corticosteroids. The guidance also discusses considerations and approaches for estimating key study parameters and sample size for the pivotal vasoconstrictor BE study.

This guidance finalizes the draft guidance of the same title issued in October 2022, replaces the guidance of the same title issued in June 1995, and represents FDA’s current thinking on this topic. For full details, please refer to the final guidance.

As part of the Drug Competition Action Plan, FDA is publishing this guidance to clarify the agency’s recommendations regarding BE information and studies submitted for topical corticosteroid product applications, provide assistance to potential ANDA applicants, and support patient access to lower-cost, high-quality medicines.

This is an automated message delivery system. Replying to this message will not reach DDI staff. If you have comments or questions, please contact us at: 1-888-INFO- FDA (1-888-463-6332) or 301-796-3400 from 8:00 am - 4:30 pm ET Monday - Friday. You can also email us at: druginfo@fda.hhs.gov.