Drugs

New TDS Generic Drug Development Guidances

FDA has issued guidances to advance development of transdermal and topical delivery systems (TDS) as part of a broader effort to bring generic competition to the drug marketplace. FDA commissioner Scott Gottlieb says 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The first draft guidance, Assessing Adhesion with Transdermal and Topical Delivery Systems for ANDAs, gives agency advice for designing and conducting studies evaluating the adhesive performance of a proposed generic TDS. A second draft, Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs, has recommendations for designing and conducting studies to evaluate the in vivo skin irritation and sensitization potential for a proposed generic TDS.

In addition to the two drafts, the agency also has issued 25 product-specific guidances, including two new and 23 revisions, to support industry in identifying appropriate science-based methodologies and evidence for developing generic TDS products.

“These draft guidances are aimed at ensuring that we provide as much scientific and regulatory clarity as possible with respect to complex generic drugs,” Gottlieb says. “…In the coming months, we’re going to advance other new policies to promote more generic competition for these complex drugs. This includes the development of new analytical tools and in vitro tests that may be more accurate and sensitive, and reproducible tools to demonstrating sameness between a generic and branded version of a complex drug. More efficient tools for demonstrating sameness can reduce product development time and cost and inform regulatory decisions. We’ll also be issuing 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. This umbrella guidance will be followed by a series of more targeted guidances to help address legal questions that may be blocking generic competition.”

Finally, Gottlieb says, the agency will clarify its policies on how it evaluates potential differences in instructions for using complex generic drugs, such as when there are directions for how to use a specific drug delivery device in an approved drug-device combination.

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