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FDA submits recommendations for Generic Drug User Fee Act


WASHINGTON — The Food and Drug Administration has finished and sent to Congress its recommendations for a proposed Generic Drug User Fee Act, drawing praise from the generic drug industry.

GDUFA calls for the generic industry to pay $299 million per year for five years, in addition to what Congress gives the FDA. The money would come in the form of user fees for companies that submit regulatory approval applications to the agency for review.

Over the years, the agency has racked up a backlog of more than 1,000 generic drug approval applications and, according to the Generic Pharmaceutical Association, it takes 31 months for the FDA to review an application submitted electronically. Supporters, such as the GPhA, hope that GDUFA will help reduce the wait time to 10 months and eliminate the backlog by the end of fiscal year 2017.

"This is an important landmark that could not have been achieved without the extraordinary efforts of the FDA, my colleagues in the generic industry and all other stakeholders," GPhA president and CEO Ralph Neas said. "We now look forward to working with members of Congress in the weeks and months ahead to ensure that the final program is one that expedites access to low-cost, high-quality generic drugs for Americans and further safeguards the quality and accessibility of our nation's drug supply."

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