FDA makes big progress on GDUFA backlog

SILVER SPRING, Md. — The Food and Drug Administration’s Center for Drug Evaluation and Research has achieved its goal of clearing some of the backlog under the Generic Drug User Fee Agreement, according to an email sent by CDER director Janet Woodcock. 

 

The agency has acted on more than 90% of backlogged applications for generics and prior approval supplements that were pewith FDA or industry as of Oct. 1, 2012. This puts the agency more than a year ahead of schedule, under the five-year funding period authorized by GDUFA, the FDA is required to clear the backlog by Sept. 30, 2017. 

 

“Most applications from the backlog will need to come back to FDA for additional review before approval is possible, so we still have a lot of work ahead of us,” Woodcock’s email said. “But this is a significant milestone. We are exceeding our negotiated GDUFA commitments.”