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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

Joint FDA, MHRA and Health Canada Symposium on Good Clinical Practice and Pharmacovigilance to be hosted on February 13 through February 15 2024

Hear first-hand from regulators on updates in the post pandemic world

Event covers global clinical trials, bioequivalence and pharmacovigilance

Sick Asian business woman at workplace holding hand on stomach from acute pain

First oral treatment approved for paroxysmal nocturnal hemoglobinuria

New medication for adults with this rare blood disorder

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Discover noteworthy scientific and research-oriented activities conducted within CDER.

CDER research looks at safety outcomes in biosimilar "switching"

Analysis shows switching is not associated with major safety events

Recent News

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Video series highlights how FDA regulates and approves drugs

Learn how the agency uses science and data to ensure drug safety, quality and efficacy
Small Business and Industry Assistance Webinars

Two webinars to provide guidance on various aspects of drug interactions

FDA will discuss therapeutic protein products, gastric pH level and more
Spotlight on CDER Science

Modeling helps scientists learn about factors affecting drug delivery

Study can help in the development and approval of generic nasal drugs

Navigate the Drugs Section

FDA Initiatives

Two men standing on an outdoor basketball court.
Don’t Get Burned is a component of FDA’s national campaign to raise awareness about sun safety and encourage proper sunscreen use and application.

FDA Health Playbook Campaigns

PSAs inform consumers about the safe use and disposal of FDA-regulated products
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The overdose crisis is an evolving public health crisis.

FDA Overdose Prevention Framework

The agency and HHS are working together to address the public health emergency
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Accelerating Rare disease Cures (ARC) Program

New initiative supports delivery of treatments for patients with a rare disease

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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Your source for the latest drug information.
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