Drugs

Generic Drugs

The FDA generic drugs program makes high quality affordable medicines available to the public.

In the United States, 9 out of 10 prescriptions filled are for generic drugs. Increasing the availability of generic drugs helps to create competition in the marketplace, which then helps to make treatment more affordable and increases access to healthcare for more patients.

The FDA's Office of Generic Drugs (OGD) within the Center for Drug Evaluation in Research ensures that people have access to safe, affordable generic drugs by following a rigorous review process that includes:

New Educational Resources

  • Managing the regulatory process to facilitate drug approvals,
  • Establishing science initiatives to research generic drugs,
  • Publishing data and reports on generic drug development and review, and
  • Offering educational materials and information.

 

Overview & Basics Overview & Basics

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, guidance, reports, and other resources to help facilitate generic drug applications and approvals

 
Approval & Reports Approvals & Reports

First-time generic drug approvals, generic drug application review metrics, and Generic Drugs Program reports

 
Science & Research Science & 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, PSAs, and articles about generic drugs for educators, health care professionals, and consumers

 

 

Page Last Updated: 09/14/2017
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