The Office of Research and Standards, a sub-office of the FDA Office of Generic Drugs, supports the regulatory science 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 providing access to 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 2019 GDUFA Science and Research Report NEW
- FY 2020 Generic Drug Regulatory Science Initiatives Public Workshop (May 4, 2020) NEW
- FY 2018 GDUFA Science and Research Outcomes
- Impact Story: Developing New Ways to Evaluate Bioequivalence for Topical Drugs
- Nanotechnology Characterization Laboratory Unveils New Technical Services for Drug Developers (March 9, 2018)