Office of Generic Drugs

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Who We Are:

The Office of Generic Drugs (OGD) ensures high-quality, affordable generic drugs are available to the American public. Generic drugs account for more than 90 percent of prescriptions filled in the United States. FDA-approved generic drugs have the same high quality, strength, purity and stability as brand-name drugs. The generic manufacturing, packaging, and testing sites used must pass the same quality standards as those of brand-name drugs.

What We Do:

• Review applications for the approval of generic drugs (known as abbreviated new drug applications or ANDAs).
• Serve as the central point of contact between applicants and the FDA Generic Drug Program.
• Provide guidance and regulatory oversight to industry on a wide variety of clinical, scientific, and regulatory matters relating to generic drugs.
• Ensure that FDA fulfills Generic Drug User Fee Amendments review commitments.
• Conduct and administer research in support of the GDUFA Regulatory Science Plan.
• Interact with external stakeholders such as physicians, pharmacists, patients, and patient advocacy groups to investigate reports of adverse events or therapeutic inequivalence of generic drugs.

Office Organization:

• Office of Generic Drugs Immediate Office
• Office of Bioequivalence
• Office of Generic Drug Policy
• Office of Regulatory Operations
• Office of Research and Standards
• Office of Safety and Clinical Evaluation

Contact Us:

• E-mail: genericdrugs@fda.hhs.gov | Phone: 240-402-7920 | Fax: 301-595-1147
• Office of Generic Drugs, Immediate Office, 10903 New Hampshire Avenue, Silver Spring, MD 20993
• OGD Division of Project Management Contact List

Additional Resources

• Generic Drugs Program
• First Generic Drug Approvals
• Activities Metrics and Other Reports
• Office of Generic Drugs (OGD) Annual Reports
• Product-Specific Recommendations for Generic Drug Development (formerly BE Guidances)
• Guidances Related to Generic Drugs
• Federal Register Notices Related to Generic Drugs
• Recent Presentations
• GDUFA Regulatory Science

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