Gottlieb Previews Upcoming Guidances on Complex Generics

The FDA is working to develop and finalize a handful of new guidances on bringing complex generics to market — including drug-device combination products that may be blocked by iterative patents.

At the agency’s Generic Drug Science Day, Commissioner Scott Gottlieb offered a small preview of the upcoming documents and policies, but did not offer details on when they would be published.

The FDA is currently finalizing a draft guidance that urges sponsors to minimize device design changes in generic drug delivery products, and outlines how differences could threaten substitutability.

However, the final version will clarify new agency policies that will allow certain labeling differences stemming from permitted changes in the generic product’s design, Gottlieb said.