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Guidance Issuing OfficeCenter for Drug Evaluation and Research
The purpose of this guidance is to provide FDA’s current thinking about local safety assessment for the risk of contact dermatitis (irritant, allergic, and photoallergic) during development of new drug products intended for topical application to the skin. The recommendations in this guidance are informed in part by the public workshop entitled “Human Dermal (Skin) Safety Testing for Topical Drug Products,” which FDA hosted on September 10, 2018.
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:
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-2020-D-0043.