THIS THURSDAY: Register today for our
March 13 update on FDA’s
efforts related to model master files (MMFs).

Don’t miss Model Master Files:
Advancing Modeling and Simulation in Generic
Drug Development and Regulatory Submissions.

Scientists in Lab

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