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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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Recent News

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Drug safety communication logo

FDA investigating severe hypocalcemia in dialysis patients on Prolia

Nov 22 - Increase calcium supplementation and blood level monitoring
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FDA issues Federal Register Notice regarding access to naloxone products

Nov 15 - Assesses certain products may be safe and effective for over-the-counter use

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FDA alerts health care professionals of risks to patients exposed to xylazine

Nov 8 - Naloxone may not be effective in reversing overdoses involving xylazine

Upcoming Events

Graphic with text overlay on a dark blue background. Header text reads CDER Small Business and Industry Assistance. Title Text reads FDA Clinical Investigator Training Course 2022. Dateline reads December 7th and 8th.

FDA to highlight agency’s approach to the evaluation of clinical trials

Course will cover issues related to investigational medical products
Blue and white graphic with text overlay. Header text reads CDER Small Business and Industry Assistance. Title text reads DMF Workshop: GDUFA III Enhancements and Structured Data Submissions. Dateline at the bottom reads November 30, 2022.

Drug Master File (DMF) Workshop to outline new GDUFA III DMF enhancements

Event will also address future state of DMF submissions and assessments
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FDA to provide overview of compounding post-inspection expectations

Will address Form 483 responses, examples, closeout meetings and more

Navigate the Drugs Section

Trending Topics

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Disposal of Unused Medicines: What You Should Know

The short video shows you how to properly get rid of unused or expired medication
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Grandmother is measuring her blood pressure in the living room.

High Blood Pressure–Understanding the Silent Killer

It can lead to many serious problems that’s why it’s important to know your risk factors

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BeSafeRx: Your Source for Online Pharmacy Information

Explore resources and tools so you can safely buy prescription medicines online

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

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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