Center for Drug Evaluation and Research

Who We Are

The Center for Drug Evaluation and Research (CDER) performs an essential public health task by making sure that safe and effective drugs are available to improve the health of people in the United States.

As part of the U.S. Food and Drug Administration (FDA), CDER regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs. This work covers more than just medicines. For example, fluoride toothpaste, antiperspirants, dandruff shampoos and sunscreens are all considered drugs.

What We Do

• Oversee prescription drugs, generic drugs, biosimilars, and over-the-counter drugs.
• Use science and data to ensure drug safety, quality and efficacy.
• Streamline the drug development process and ensure drugs are safe and effective.

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• Provide drug information for consumers and patients, health care providers and professionals, industry, and more.
• Make recommendations to update drug labeling.