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# Draft Guide on Drug Patch Adhesion Studies
- URL: https://www.fdaweb.com/draft-guide-on-drug-patch-adhesion-studies/
- Published: 2018-10-10T12:00:00.000Z
- Updated: 2026-09-15T00:37:10.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5142557

*Federal Register* notice: FDA has made available a revised draft guidance entitled “Assessing Adhesion With Transdermal and Topical Delivery Systems for ANDAs.” The document provides recommendations for the design and conduct of studies evaluating the adhesive performance of a transdermal or a topical delivery system (TDS). Depending on the objectives of a TDS product development program, the agency says applicants may choose to evaluate TDS adhesion in clinical studies performed to evaluate TDS adhesion only or in clinical studies performed with a combined purpose (e.g., for the simultaneous evaluation of adhesion and bioequivalence with pharmacokinetic endpoints). To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2018-10-10/pdf/2018-21959.pdf?ref=fdaweb.com).