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Center for Drug Evaluation and Research (CDER)

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

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Additional Resources

Reports: NDAs, BLAs, ANDAs, & INDs

Review application approval reports for new drugs (NDAs), biologic licenses (BLAs), abbreviated new drugs (ANDAs), and investigational new drugs (INDs).

Human Drug Advisory Committees

Advisory committees provide FDA with independent opinions and recommendations from outside experts on applications to market new drugs, and on FDA policies.

FOIA Electronic Reading Room

The Freedom of Information Act (FOIA) Electronic Reading Room provides copies of CDER records that have been made publicly available on the web.

User Fee Programs

User Fee programs help the FDA fulfill its mission of protecting public health and facilitating regulated product innovative.

Jobs at CDER

Find mid-grade to executive level positions for individuals with administrative, scientific, and/or information technology backgrounds.

Request a CDER Speaker

Request a CDER employee to give a speech, make a presentation, or participate on a panel, meeting, or webinar related to CDER regulations and initiatives.

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