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  1. CDER Offices and Divisions

Office of Generic Drugs


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:

Contact Us:

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