FDA efforts to advance the development of generic copies of complex drugs to improve patient access to medicines

FDA announced on Tuesday a series of guidance documents to further the development of generic transdermal and topical delivery systems (TDS).

FDA announced on Tuesday a series of guidance documents to further the development of generic transdermal and topical delivery systems (TDS). According FDA Commissioner Scott Gottlieb, "The increased transparency and predictability provided by these and other product-specific recommendations gives applicants seeking to develop generic copies of these complex products a better opportunity to efficiently advance these products and prepare better and more complete submissions." The guidances include the revised draft guidance, Assessing Adhesion with Transdermal and Topical Delivery Systems for ANDAs, and a second draft guidance, Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs. FDA is also releasing 25 product-specific guidance documents, including 2 new and 23 revised guidances, to support industry in identifying appropriate science-based methodologies and evidence for developing generic TDS products. Going forward, FDA plans to further other new policies to promote more generic competition for these complex drugs, Gottlieb said, and the agency will issue an umbrella guidance to help generic drug developers address some of the most challenging regulatory and scientific issues encountered when they try to make generic copies of complex drugs. Gottlieb noted, "Addressing these challenges—and promoting more generic competition to complex medicines—is a key part of our Drug Competition Action Plan, and our efforts to promote patient access and more affordable medicines."