Docket Number:
FDA-2020-D-0043
Issued by:
Guidance Issuing Office
Center 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.

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