Small Business Assistance

Generic Drug Review Process

A generic drug product is one that is comparable to an innovator drug product in dosage form, strength, route of administration, quality, performance characteristics and intended use.  An important part of CDER's mission is to assure that safe and effective generic drugs are available to the American people.  This work is accomplished in CDER's Office of Generic Drugs (OGD).  The information below provides an understanding of how CDER works to assure the safety and effectiveness of generic drug products. For more information on generic drug applications, please see the Generic Drug Applications Webpage.

• Generic Drug Review Process  An interactive chart that provides an overview of CDER's abbreviated new drug application (ANDA) review process, and how CDER determines the safety and bioequivalence of generic drug products prior to approval for marketing.

• Office of Generic Drugs Home Page Links to monthly drug approval lists, labeling information, bioequivalence information, and more.

• The FDA Process for Approving Generic Drugs (free online training course)

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FDA/Center for Drug Evaluation and Research
Last Updated: January 2, 2009
Originator: OTCOM/DML
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