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GUIDANCE DOCUMENT

Topical Dermatologic Corticosteroids: In Vivo Bioequivalence October 2023

Download the Draft Guidance Document Read the Federal Register Notice
Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2022-D-2170
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

This guidance is intended to assist applicants who submit abbreviated new drug applications (ANDAs) for topical dermatologic corticosteroid products of all potency groups hereinafter referred to as topical corticosteroids. This guidance describes recommendations for in vivo studies to demonstrate the bioequivalence of topical corticosteroids.

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

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Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2022-D-2170.

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