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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

From Our Perspective

Recent actions highlight FDA’s effort to prevent opioid overdose deaths

Feb 2 - Agency’s focus is on expanding the availability of and access to naloxone
CDER Small Business and Industry Assistance Webinars www.fda.gov/CDERSBIALearn

FDA, Health Canada to discuss ICH guidelines reaching key milestones

Feb 2 - Will focus on continuous manufacturing, viral safety evaluation and more
Blue and translucent graphic with text that reads: Fiscal Year 2022 GDUFA Science and Research Report

FDA publishes fiscal year 2022 GDUFA Science and Research Report

Jan 31 - Details research activities around generic drug development

Recent News

CDER Small Business and Industry Assistance Webinars www.fda.gov/CDERSBIALearn

FDA to discuss clinical pharmacology considerations for neonatal studies

Jan 25 - Will review guidance for the inclusion of neonates in drug development
CDER Conversation with Sarah Yim and Steven Kozlowski
Drs. Sarah Yim and Steven Kozlowski

CDER offices highlight enhancements to biosimilar programs

Jan 12 - Experts discuss BsUFA III goals and biosimilar regulatory science program
Senior short gray-hair woman wearing eyeglasses using asthma inhaler while sitting on sofa ta home during the day.
Asthmatic woman using an inhaler.

Combination treatment approved for adults with mild to severe asthma

Jan 11 - First short-acting inhaler to contain a corticosteroid

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
Senior adult woman measuring blood pressure at home.
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

Person Using Cell Phone in a Pharmacy

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

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(855) 543-3784
(301) 796-3400

Hours Available

CDER Division of Drug Information

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