USA – Topical Drug Products for Cutaneous Application: Human Safety Assessment Guidance

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.

This 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, evaluation of nonprescription drug ingredients to determine whether they are “generally recognized as safe,” or development of generic drug products. It also does not address phototoxicity (photoirritation), as this topic has been addressed in the ICH guidance for industry S10 Photosafety Evaluation of Pharmaceuticals (January 2015).

In general, FDA’s guidance documents do not establish legally enforceable responsibilities.
Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required…