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  • As User Fee Bill Sails Through House Committee Vote, a Focus on Industry Efforts

    The House Energy and Commerce Committee advanced the Food and Drug Administration (FDA) Reform Act of 2012 , a package of proposals to both fund and reform the agency, by a unanimous vote involving 46 members of the House of Representatives. "The legislation ensures continuation of various FDA programs, including the Prescription Drug User Fee Act and Medical Device User Fee Act , and authorizes new user fee programs, the Generic Drug User Fee Act and Biosimilar...
  • House Committee to Vote on User Fee Bill, Aiming for Passage in July

    The US House of Representatives' Energy and Commerce Committee is set to hold a vote on Thursday, 10 May on a collection of user fee legislation being dubbed the Food and Drug Administration (FDA) Reform Act of 2012 . The bill would reauthorize the Prescription Drug User Fee Act and the Medical Device User Fee Act , authorize the Generic Drug User Fee Act and the Biosimilars and Interchangeable Products User Fee Act , and make a number of reforms to FDA's review...
  • Report: Fight Over FDA User Fee Bills Threatening To Derail Legislation

    Riders and add-ons in legislation intended to help fund the US Food and Drug Administration (FDA) through industry-paid user fees are threatening to derail the entire legislation, reports  Politico . A number of user fee bills, including the Prescription Drug User Fee Act, the Medical Device User Fee Act , the Generic Drug User Fee Act and the Biosimilars and Interchangeable Products User Fee Act are all being wrapped up into a single piece of legislation ins...