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# Draft Guide on Topical Drug Contact Dermatitis
- URL: https://www.fdaweb.com/draft-guide-on-topical-drug-contact-dermatitis/
- Published: 2020-03-06T12:00:00.000Z
- Updated: 2026-09-14T16:06:05.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5146265

FDA has released a draft guidance (XXINSERT LINKXX) on “Contact Dermatitis from Topical Drug Products for Cutaneous Application: Human Safety Assessment.” The document discusses local safety assessments for the risk of contact dermatitis (irritant, allergic, and photoallergic) when developing topical drug products. The recommendations were developed based in part on discussions at a 9/2018 public workshop entitled “Human Dermal (Skin) Safety Testing for Topical Drug Products.” FDA notes that the guidance does not address local safety assessment for other cutaneous adverse reactions (e.g., hyperpigmentation, atrophy) for topical drug products, local safety assessment for transdermal systems, nonprescription drug ingredient evaluations to determine whether they are “generally recognized as safe,” or for developing generic drug products.