FDA Completes Review of GDUFA Backlog

July 11, 2016
Pharmaceutical Technology Editors

The agency announced that it has completed the review of the GDUFA backlog one year ahead of schedule.

In an email statement sent on July 11, 2016, Janet Woodcock, director of the FDA Center for Drug Evaluation and Research (CDER) announced that as of July 1, 2016 FDA has met its Generic Drug User Fee Amendments (GDUFA) commitment. According to Woodcock, the agency has completed its goal of reviewing 90% of the GDUFA backlog more than a year ahead of schedule.

FDA committed to reviewing and taking regulatory action on 90% of the GDUFA backlog by Sept. 30, 2017, the end of the five-year GDUFA funding period. Although most of the applications will have to be re-reviewed by FDA before the drugs are approved, Woodcock says this is a “significant milestone” for the agency.

Earlier this year, FDA said it was making steps to modernize the generic-drug review process. In a blog published on FDA’s website, Steven Ostroff commented the agency was working to decrease the backlog and increase patient access to more affordable generics. The agency is slated to release GDUFA II, an updated version of the amendments, in early 2017 with the goal of bringing more affordable generics to market.

Source: CDER