The Office of Research and Standards, within the FDA's Office of Generic Drugs (OGD), supports the Science and Research program established under the Generic Drug User Fee Amendments (GDUFA). In collaboration with industry and the public, FDA creates an annual list of regulatory science initiatives on generic drugs. The research studies conducted under these initiatives advance public health by contributing to the development of safe and effective generic drugs. The results provide new tools for FDA to evaluate generic drug equivalence and for industry to efficiently develop new generic products.
Latest Science & Research News
- FY 2021 GDUFA Science and Research Report
- FY2022 Generic Drug Regulatory Science Initiatives Public Workshop (May 9-10, 2022)
- Save the Dates for 2022 FDA and CRCG Co-Sponsored Events on Complex Generic Product Topics
- Impact Story: Developing New Ways to Evaluate Bioequivalence for Topical Drugs
- Impact Story: Modeling Tools Could Modernize Generic Drug Development