In the United States, 9 out of 10 prescriptions filled are for generic drugs. The increased availability of generic drugs helps create market competition, which helps make treatment more affordable and increases access to health care for more patients. Learn more about the FDA Action Plan on Drug Competition.

The FDA’s Office of Generic Drugs (OGD) within the Center for Drug Evaluation in Research ensures that affordable, high-quality generic drugs are available to the American public by following a rigorous review process that includes:

New educational resources

  • Manage the regulatory process to facilitate drug approvals,
  • Establish scientific initiatives for generic drug research,
  • Publish data and reports on generic drug development and review, and
  • Provide educational materials and information.

Presentation and basic notions Presentation and basic notions

Information about the generic drug review process, FDA standards and pricing, and answers to frequently asked questions

Industry Resources Industry Resources

Electronic submission forms, requirements, tips, reports and other resources to help facilitate generic drug applications and approvals

Approval and reports Approvals and reports

First-time generic drug approvals, generic drug application review metrics, and generic drug program reports

Science and research Science and research

FDA Generic Drug Regulatory Science Initiatives, Research Priorities and Reports, Public Workshops, and Opportunities for Collaboration

Patient Education Patient Education

Infographics, brochures, handouts, posters, presentations, public service announcements and articles on generic drugs for educators, healthcare professionals and consumers

Learn more about the Bureau of Generic Drugs

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