FDA Releases New Draft Guidance to Aid Development of Generic Versions of Complex Drugs

October 9, 2018

On 10/9/18 FDA Commissioner, Scott Gottlieb MD, announced a series of guidance documents meant to advance the development of drugs that, “by nature of their formulation or delivery systems for example, are harder to “genericize” under our traditional approaches.” The statement focused on transdermal and topical delivery systems (TDS), but also referenced 25 product specific guidance documents that were either new or revised as part of the effort.

The new guidances released that concern TDS include the revised draft guidance, Assessing Adhesion with Transdermal and Topical Delivery Systems for ANDAs, which provides updated advice for the design and conduct of studies evaluating the adhesive performance of a proposed generic TDS. A second draft guidance, Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs, provides recommendations for the design and conduct of studies to evaluate the in vivo skin irritation and sensitization potential of a proposed generic TDS.

Gottlieb said that, “These draft guidances are aimed at ensuring that we provide as much scientific and regulatory clarity as possible with respect to complex generic drugs. This focus is critical because, first and foremost, these drug products provide important therapies to patients. We believe they’re also becoming increasingly significant to the economic health of the generic drug industry. Being able to “genericize” a complex drug can be a high-value opportunity for a generic drug developer.”

The commissioner also said that in the coming months, the FDA would release other new policies to promote the development of generic development of complex drugs. The new policies will include 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 drugs.




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