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In this section: Center for Drug Evaluation and Research (CDER)

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.

CDER Organization Chart

CDER Offices & Divisions

CDER Leadership Bios

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.

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CDER Initiatives

CDER programs and campaigns that streamline the drug development process, advance public health, and help ensure human drugs are safe and effective.

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News & Events for Human Drugs

Discussions with key CDER leadership, procedural and scientific advancements in drug development and safety, and FAQs with FDA.

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CDERLearn

Continuing Education (CE) courses and training opportunities for health care professionals and academia on drug regulation.

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FDA-TRACK: CDER Performance Dashboard

CDER performance measures in policy and science development, pre-approval safety review, and post-approval safety monitoring.

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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