FDA Releases New Draft Guidance to Aid Development of Generic Versions of Complex Drugs

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.