The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry titled "Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs." This revised draft guidance provides recommendations for the design and conduct of studies to evaluate the in vivo skin irritation (and sensitization, if applicable) potential of a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). The recommendations in this revised draft guidance relate to studies submitted in support of an abbreviated new drug application (ANDA). The revised draft guidance is intended to clarify FDA's recommendations and expectations related to in vivo skin irritation and in vivo combined skin irritation and sensitization studies. This draft guidance replaces the draft guidance "Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs" (April 2023).
US Federal Register - FDA Guidance Notices · August 03, 2026
Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs; Revised Draft Guidance for Industry
Original title: Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs; Revised Draft Guidance for Industry; Availability
FDA revises draft guidance on in vivo skin irritation and sensitization study design and conduct for transdermal and topical delivery systems in ANDAs.
Published by US Federal Register - FDA Guidance Notices. HealthSignal links to the original document; the summary above is extracted from the source text.