Assessing Adhesion With Transdermal and Topical Delivery Systems for ANDAs Guidance for Industry July 2026

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/assessing-adhesion-transdermal-and-topical-delivery-systems-andas?utm_medium=email&utm_source=govdelivery FDA publishes a new final guidance for industry, “Assessing Adhesion with Transdermal and Topical Delivery Systems for ANDAs”, and a new revised draft guidance for industry, “Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs” On August 3rd, the Food and Drug Administration (FDA) will publish a final and revised draft guidance related to the design and conduct of studies for evaluating transdermal and topical delivery systems (TDS) submitted in supported of abbreviated new drug applications (ANDAs). These publications, which apply to TDS products submitted in ANDAs, include the following: The final guidance for industry entitled, “Assessing Adhesion with Transdermal and Topical Delivery Systems for ANDAs.” Assessing Adhesion With Transdermal and Topical Delivery Systems for ANDAs Draft Guidance for Industry | FDA This guidance finalizes the draft guidance for industry of the same title which was announced in the Federal Register on April 13, 2023 (88 FR 22456). FDA received no comments on the revised draft guidance (Revision 2) and, thus, no comments were considered before publication of this guidance. This final 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 endpoints). FDA recommends that applicants consult this guidance in conjunction with any relevant product-specific guidances for industry when considering the design and conduct of studies that may be appropriate to support the BE of a proposed generic TDS product to its reference listed drug and/or reference standard product. FDA also recommends that an applicant who seeks to use an alternative approach to FDA’s recommendations for the design and conduct of studies evaluating the adhesion performance of a TDS contact the Agency to discuss the proposed alternative approach to evaluate adhesion performance for that particular drug product. As part of the Drug Competition Action Plan, FDA is publishing this final guidance to increase competition in the marketplace for prescription drugs, facilitate the entry of high-quality and affordable generic drugs, and improve public health. This guidance finalizes the draft guidance for industry of the same title issued on April 13, 2023. This final guidance assists applicants with the design and conduct of studies evaluating the adhesion performance of a TDS by providing clear information that will reduce duplicative efforts, regulatory delays, and process uncertainties for industry. It also streamlines FDA's application review process, resulting in efficient and timely reviews. https://www.fda.gov/drugs/guidance-compliance-regulatory-information/fda-drug-competition-action-plan?utm_medium=email&utm_source=govdelivery By saving time and resources that lead to faster approval of generic products, the American public will see more treatment options and cost savings. The revised draft guidance for industry entitled, “Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs.” Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs | FDA 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 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. As part of the Drug Competition Action Plan, FDA is publishing this revised draft guidance to increase competition in the marketplace for prescription drugs, facilitate the entry of high-quality and affordable generic drugs, and improve public health. This revised draft guidance replaces the April 2023 draft guidance of the same name. This revised draft guidance assists applicants by providing clear information that will reduce duplicative efforts, regulatory delays, and process uncertainties for industry, as well as time spent by FDA reviewing applications. By saving time and resources that lead to faster approval of generic products, providing the American public with more treatment options and cost savings.