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.

Priorities and Projects: Learn more about FDA generic drug research priorities, public workshops, and awarded projects

Research Publications and Resources: Browse FDA generic drug research published in scholarly journal articles, presentations, and posters

Guidances and Reports: View FDA generic drug regulatory science publications, including product-specific guidances and annual reports

Collaboration Opportunities: See a listing of available grant and fellowship opportunities

Latest Science & Research News

FDA-CRCG Co-Sponsored Workshop on Bioequivalence Innovations for Generic Oral Products: Biowaivers, Bridging, and Development for Oncology and Discontinued Products
Date: May 5-6, 2026
FY 2026 Generic Drug Science and Research Initiatives Public Workshop
Date: June 8-9, 2026
Virtual Workshop: Advancing Generic Drug Development: Bioequivalence Challenges and Approaches of Patient-Centric Oral Formulations
Date: June 11, 2026