The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry titled "Assessing Adhesion With Transdermal and Topical Delivery Systems for ANDAs." This guidance provides recommendations for the design and conduct of studies evaluating the adhesion performance of a transdermal or topical delivery system (collectively referred to as TDS). Depending on the objectives of a generic TDS product development program, applicants may choose to evaluate TDS adhesion in studies performed to evaluate TDS adhesion only, or in studies performed with a combined purpose (e.g., for the simultaneous evaluation of adhesion and bioequivalence (BE) with pharmacokinetic (PK) endpoints). The recommendations in this guidance relate to studies submitted in support of an abbreviated new drug application (ANDA). The guidance replaces the draft guidance (Revision 2) "Assessing Adhesion With Transdermal and Topical Delivery Systems for ANDAs," issued on April 13, 2023.
US Federal Register - FDA Guidance Notices · August 03, 2026
Assessing Adhesion With Transdermal and Topical Delivery Systems for ANDAs; Guidance for Industry
Original title: Assessing Adhesion With Transdermal and Topical Delivery Systems for ANDAs; Guidance for Industry; Availability
FDA guidance on study design and conduct for evaluating adhesion performance of transdermal and topical delivery systems in generic drug applications.
Published by US Federal Register - FDA Guidance Notices. HealthSignal links to the original document; the summary above is extracted from the source text.