Opportunity
Federal Register #FDA-2016-D-1254
FDA Final Guidance on Adhesion Assessment for Transdermal and Topical Delivery Systems (TDS) for ANDAs
Buyer
Food and Drug Administration
Posted
August 03, 2026
Identifier
FDA-2016-D-1254
This notice announces the release of a final guidance document by the Food and Drug Administration (FDA) regarding adhesion assessment for transdermal and topical delivery systems (TDS) in support of Abbreviated New Drug Applications (ANDAs). - Government Buyer: - Department of Health and Human Services (HHS) - Food and Drug Administration (FDA) - No OEMs or vendors are named in this notice - No products or services are being procured - Key details: - The guidance provides recommendations for designing and conducting studies to evaluate the adhesion of TDS products - Applies to generic drug developers submitting ANDAs - Guidance may be used for studies evaluating adhesion alone or in combination with bioequivalence studies - Replaces a previous draft guidance - No purchase quantities, part numbers, or procurement requirements are included - The notice is informational and supports regulatory compliance for generic TDS products
Description
The Food and Drug Administration (FDA) has announced the availability of a final guidance titled "Assessing Adhesion With Transdermal and Topical Delivery Systems for ANDAs." This guidance provides recommendations for designing and conducting studies to evaluate the adhesion performance of transdermal or topical delivery systems (TDS). It applies to studies supporting abbreviated new drug applications (ANDAs) and replaces the draft guidance issued on April 13, 2023. Applicants may evaluate adhesion alone or in combination with bioequivalence studies with pharmacokinetic endpoints.