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 largest user fee program to directly support regulatory science research activities illustrating the importance of regulatory science innovation in the generic drug program.
- GDUFA Commitment Letter: Human Generic Drug Performance Goals and Procedures Fiscal Years 2013 through 2017 (PDF - 99KB)
FY 2013 Awarded GDUFA Regulatory Research Contracts and Grants(PDF - 93KB) FY 2013 Awarded GDUF Regulatory Research Contracts and Grants Extensions - FY2014 Extension or Expansion(PDF - 101KB)
- FY 2014 GDUFA Regulatory Research Priorities
FY 2014 Awarded GDUF Regulatory Research Contracts and Grants(PDF - 116KB)