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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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Palm trees blowing in the wind on a cloudy day, representing hurricane preparedness. Learn how you can prepare for disasters before they happen.

Hurricane Helene: Baxter's manufacturing recovery in North Carolina

Find information and updates on CDER-regulated drug and biologic products affected by the hurricane.

Learn more
Consumer Contact Information Drug Alerts and Statements What's New Related to Drugs

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

Shot of a young woman browsing the shelves of a pharmacy

Proposed order seeks to remove active ingredient in nasal decongestant

New data shows oral phenylephrine is safe, but not effective
DNA structure on blue background with Rare Disease Innovation Hub text

FDA takes steps toward establishing the Rare Disease Innovation Hub

Hub allows CDER and CBER to collaborate on cross-cutting rare disease issues
Doctor standing next to different medical science icons

FDA approves opioid analgesic REMS modification

Drug mail-back envelopes required to accompany opioid prescriptions

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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