FDA marks GDUFA milestones

Agency has reduced generic drug application backlog by more than 30%

SILVER SPRING, Md. — The Food and Drug Administration has made a significant dent in its large backlog of generic drug applications thanks to amendments to last year's reauthorization of the Prescription Drug User Fee Act, the agency said Tuesday.

The FDA's Center for Drug Evaluation and Research said its Office of Generic Drugs had finished reviewing more than 30% of backlog applications since the passage of the Generic Drug User Fee Amendments while streamlining the process of hiring new scientific reviewers, project managers, investigators and support staff. The FDA plans to bring on board at least 25% of GDUFA program hires by the beginning of October.

In addition, the agency has put in place other improvements designed to ease communication between it and drug companies during the review process, including more detailed complete-response letters, letters the FDA sends to companies when it has completed reviewing a drug-approval application, but issues remain that preclude final approval.

The amendments were part of an effort to improve the generic drug review system at the FDA, which had long struggled with a backlog of more than 2,000 generic drug applications due to insufficient staffing and funding.

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