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GUIDANCE DOCUMENT

Topical Dermatologic Corticosteroids: in Vivo Bioequivalence June 1995

Final
Docket Number:
FDA-2021-D-0384
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

This guidance provides recommendations to pharmaceutical sponsors on methods to document in vivo bioequivalence of topical dermatologic corticosteroids, hereinafter referred to as 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))

If unable to submit comments online, please mail written comments to:

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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-2021-D-0384.

 
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