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In this section: Drugs

Drugs

The Center for Drug Evaluation and Research (CDER) ensures that safe and effective drugs are available to improve the health of the people in the United States

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About CDER

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.

Drugs@FDA

Find information about most FDA-approved prescription, generic, and over-the-counter drug products.

Drug Shortages

Find information about drug shortages caused by manufacturing and quality problems, delays, and discontinuations.

National Drug Code Directory Search

Find information about finished drug products, unfinished drugs, and compounded drug products.

Orange Book

The Orange Book identifies drug products approved by FDA on the basis of safety and effectiveness.

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Office of Translational Sciences publishes 2023 Annual Report

Report outlines achievements and activities in science and innovation

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FDA approves drug for WHIM, a rare autoimmune syndrome

First treatment for patients 12 years of age and older

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CDER establishes Center for Clinical Trial Innovation

New center will support innovative approaches through collaboration

Drug Information, Safety, and Availability

Medication Guides, Drug Safety Communications, Shortages, Recalls

Drug Approvals and Databases

Drugs@FDA, Orange Book, National Drug Code, Recent drug approvals

Drug Development and Review Process

Drug applications, submissions, manufacturing, and small business help

Guidance, Compliance, and Regulatory Information

Guidances, warning letters, drug compounding, international information, registration and listing

Regulatory Science and Research

CDER research programs, initiatives, and resources

Emergency Preparedness

Prepare and respond to natural disasters, nuclear and chemical attacks

Updates, News, Events, and Training

Recent approvals, meetings, workshops, blogs, podcasts, stay connected

About the Center for Drug Evaluation and Research (CDER)

Our role, mission, organization, history, leadership, job openings

Center

Workshop

May 13

Natural History Studies and Registries in the Development of Rare Disease Treatments

Virtual

May 16

Statistical Considerations for Premarketing Risk Assessment

Biosimilars Education Initiative

Learn how biosimilars are safe and effective treatment options

Opioids

Reducing the impact of opioid misuse and abuse

Generics

Ensuring access to safe, affordable, and effective generic drugs

Warning Letters

Warning and Notice of Violation Letters to Pharmaceutical Companies

Guidances

FDA's current thinking on drug development and review activities

Drug Shortages

Search the database, learn about root causes and potential solutions

Resources

Information for consumers, health professionals, and industry

Disposal of Unused Medicines

Learn how to properly get rid of unused or expired medication

CENTER FOR DRUG EVALUATION AND RESEARCH

Office of Communications
10001 New Hampshire Ave
Hillandale Building, 4th Fl
Silver Spring, MD 20993

druginfo@fda.hhs.gov

Toll Free

(855) 543-3784

(301) 796-3400

Hours Available

CDER Division of Drug Information

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FOR UPDATES ON X FOLLOW

@FDA_Drug_Info

Your source for the latest drug information.
Know the moment it happens.

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