Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs: Draft Guidance for Industry

Issue Date: July 31, 2026
Issued by: Center for Drug Evaluation and Research
Topic(s): Drug Competition Action Plan, Generic Drugs
Status: Draft

Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs: Draft Guidance for Industry

This revised draft guidance provides recommendations for the design and conduct of studies to evaluate the in vivo skin irritation (and sensitization, if applicable) potential of a proposed transdermal or topical delivery system (collectively referred to as TDS).

Download the Guidance Document

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