Generic Drugs
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. Learn more about the FDA Drug Competition Action Plan.
The FDA's Office of Generic Drugs (OGD) within the Center for Drug Evaluation in Research ensures high-quality, affordable generic drugs are available to the American public by following a rigorous review process that includes:
- 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.
Approval Process
FDA approves a drug only after reviewing extensive testing showing that a drug will provide the benefits described in its labeling, and that those outweigh its risks.
Science & Research
FDA generic drug regulatory science initiatives, research priorities and reports, public workshops, and opportunities for collaboration
Complex Generics News
Generally, complex generics have complex active ingredients, formulations, dosage forms, or routes of administration, or are complex drug-device combination products.
FDA Consumer Updates
Science-based health and safety information you can trust on all FDA-approved products.
Contact Us
- Division of Drug Information
- Email: druginfo@fda.hhs.gov
- Telephone: 855-543-3784
- MedWatch: The FDA Safety Information and Adverse Event Reporting Program