FDA decrees how sticky drug patches must cling
Published Date: 8/3/2026
Notice
Summary
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 The guidance replaces the draft guidance (Revision 2) "Assessing Adhesion With Transdermal and Topical Delivery Systems for ANDAs," issued on April 13, 2023.
Analyzed Economic Effects
3 provisions identified: 3 benefits, 0 costs, 0 mixed.
Final FDA guidance for TDS adhesion
The FDA published a final guidance titled "Assessing Adhesion With Transdermal and Topical Delivery Systems for ANDAs" on August 3, 2026. The guidance gives recommendations on how to design and run studies that evaluate how well transdermal or topical delivery systems stick to the skin for applications supporting an abbreviated new drug application (ANDA).
Option: Adhesion-only or combined studies
FDA states that applicants may choose to evaluate TDS adhesion in studies performed only to assess adhesion, or in studies that combine adhesion assessment with bioequivalence (BE) testing using pharmacokinetic (PK) endpoints. These recommendations apply to studies submitted in support of an ANDA.
Consult product guidances; contact FDA for alternatives
FDA recommends that applicants consult this guidance together with any relevant product-specific guidances when planning studies, and that applicants who want to use an alternative approach contact the Agency to discuss the proposed alternative. The guidance finalizes Revision 2 (issued April 13, 2023) and notes that alternative approaches can be used if they meet applicable statutes and regulations (21 CFR 10.115).
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