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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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Prescribe with Confidence

FDA is launching a new campaign to help primary care providers recognize and treat opioid use disorder. Find free training, firsthand testimonials, and other resources to help providers get started.

Learn more

Search our databases:

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.

Orange Book

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

News

A senior woman sits across the desk from a nurse practitioner as they discuss her medications.

10 things to know about CDER's pharmaceutical quality functions

Learn how the center helps ensure drugs consistently meet quality standards
Scientist is experimenting and researching with molecules and atoms in the laboratory.

Fiscal Year 2023 GDUFA Science and Research Report now available

Report outlines generic drug scientific progress and research outcomes

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Optometrist giving eye exam to senior patient.

FDA approves two interchangeable biosimilars

Medications help slow down or stop damage to the retina and preserve vision

Navigate the Drugs Section

Center

Upcoming Drug-related Events

Priority Areas & Initiatives

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

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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@FDA_Drug_Info

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

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