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GDUFA Regulatory Science
In July 2012, Congress passed the Generic Drug User Fee Amendments (Title III of the Food and Drug Administration Safety and Innovation Act (Public Law 112-144). FDA agreed in the GDUFA Commitment Letter to immediately begin work on the FY 2013 Regulatory Science Plan in the letter and to consult with industry and the public to create an annual list of regulatory science initiatives specific to research on generic drugs. The research studies conducted under these initiatives will advance the public health by providing access to safe and effective generic drugs. The regulatory science results will provide new tools for FDA to evaluate generic drug equivalence and for industry to efficiently develop new generic products in all product categories. We implement the Office of Generic Drugs’ GDUFA Regulatory Science Research Program by collaborating within FDA as well as externally through grants or contracts. GDUFA is the only user fee to directly support regulatory science research activities illustrating the importance of regulatory science innovation in the generic drug program.