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
- Impact Story: Developing New Ways to Evaluate Bioequivalence for Topical Drugs
- GDUFA Implementation: Bi-Annual Industry Regulatory Science Work Group Meeting Minutes NEW
- FY 2019 Generic Drug Regulatory Science Initiatives Public Workshop (May 1, 2019) NEW
- Nanotechnology Characterization Laboratory Unveils New Technical Services for Drug Developers (3/9/18)