Zdrowie i gospodarka · 13/04/2023

FDA Releases Revised Draft Guidance for Evaluating Adhesion of Transdermal and Topical Delivery Systems for ANDAs

The US Food and Drug Administration (FDA) has made available a revised draft guidance for industry, titled Assessing Adhesion With Transdermal and Topical Delivery Systems for Abbreviated New Drug Applications (ANDAs), Revision 2, which provides recommendations for evaluating the adhesion performance of transdermal and topical delivery systems in studies submitted in support of an abbreviated new drug application (ANDA).