Science & Research
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
- FY2023 Generic Drug Regulatory Science Initiatives Public Workshop (May 11-12, 2023)
- FY 2022 GDUFA Science and Research Report
- Save the Dates for 2023 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