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
- In Vitro Release Test (IVRT) and In Vitro Performance Test (IVPT) Methods: Best Practices, Regulatory Standards, and Scientific Considerations – Virtual CRCG Workshop (August 18-20, 2021) NEW
- FY 2020 GDUFA Science and Research Report
- FY2021 Generic Drug Regulatory Science Initiatives Public Workshop (June 23, 2021)
- Impact Story: Developing New Ways to Evaluate Bioequivalence for Topical Drugs
- Advancing Innovative Science in Generic Drug Development Workshop (September 29-30, 2020)
- Impact Story: Modeling Tools Could Modernize Generic Drug Development