US FDA gives generics cos a leg up with 57 product-specific guidances

Shortly after the US Government Accountability Office (GAO) issued a report accusing the Food and Drug Administration of failing to include product-specific guidance documents, the agency has stepped up its efforts with 57 such documents.

There are 35 new and 22 revised guidances, with 19 in total covering so-called complex drug products, and multiple products that don’t yet have generic competition.

Complex drugs, which are often more difficult to develop generic versions of using traditional approaches, are a particular target for FDA Commissioner Scott Gottlieb.