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GUIDANCE DOCUMENT

Contact Dermatitis From Topical Drug Products for Cutaneous Application: Human Safety Assessment Guidance for Industry March 2020

Download the Draft Guidance Document Read the Federal Register Notice
Draft Level 1 Guidance

Not for implementation. Contains non-binding recommendations.

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

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5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2020-D-0043.

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