22 August 2012

Mission3: President Obama Signs PDUFA Reauthorization

On July 9, 2012, President Obama signed the reauthorization of the Prescription Drug User Fee Act (PDUFA). Under the law, Starting October 1, the generic drug industry will pay $299 million a year in user fees over the next five years, which will help pay for more FDA staff to help clear a backlog of some 2,500 generic drug applications and more inspections of manufacturers’ production plants.

The resigning of the PDUFA was the fifth reauthorization. This is an achievement for patients, industry and the FDA. The PDUFA program will make certain that all Americans receive timely access to safe, effective, and affordable generic drugs. PDUFA is considered a must-pass measure because the FDA has become reliant on the money it generates. In 2010, more than $550 million in user fees collected by the FDA covered 62% of the agency’s costs for drug reviews.

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1 comment:

  1. This is not a comment to this message but I have a general question.

    For EU ectd submissions, what is a node extension? I have a general idea that it is something used to group together the content for a specific study but how is it created?