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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

Dark blue graphic with text highlighting a new Regulatory Science Impact Story titled, "Assessing Exposure-Response Between Pediatric and Adult Patients." There is a small peek-through window of a young child smiling on a hospital bed.

CDER pursues framework to assess exposure-response between populations

August 16 - Designed to help determine efficacy of approved drugs for pediatric use
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FDA publishes complex generics news resource

August 5 - New webpage highlights FDA’s most recent complex generic-related actions
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Global Generic Drug Affairs team issues one-year progress report

July 28 - Highlights activities and accomplishments of Generic Drug Cluster

Upcoming Events

Dark blue background with text promoting the Advancing Generic Drug Development: Translating Science to Approval event on September 20 and 21

FDA to address aspects of the GDUFA Science and Research Program

Learn how outcomes guide and facilitate generic drug development
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FDA to review drug amount reporting under section 510 of the FD&C Act

Will address program scope, purpose, recommendations and scenarios
Blue graphic with white text highlighting CDER's Regulatory Best Practices for Global Access to Medicines three-day conference from August 16th to August 18th

CDER to highlight FDA’s role in international regulatory harmonization

Emphasis on strengthening systems in low- and middle-income countries

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

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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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Your source for the latest drug information.
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