Assessing Adhesion With Transdermal Delivery Systems and Topical Patches for Abbreviated New Drug Applications; Draft Guidance for Industry; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Assessing Adhesion with Transdermal Delivery Systems and Topical Patches for ANDAs.'' This draft guidance is intended to provide recommendations for the design and conduct of studies evaluating the adhesive performance of a Transdermal Delivery System or a topical patch (collectively, TDS). This guidance, once finalized, is intended to provide updated recommendations for the design and conduct of adhesion studies submitted in support of an Abbreviated New Drug Application (ANDA) for a TDS.