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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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FDA to co-host virtual workshop on rare disease clinical trials

March 28 - Event will address challenges in trial design and analysis
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Activated PI3K-delta syndrome (APDS) is a genetic disorder that impairs the immune system.

FDA approves first treatment for activated PI3K-delta syndrome

March 24 - For adult and pediatric patients 12 years of age and older
Blue and white graphic with text. Text title reads Biosimilars: What Patients Need to Know. On the right of the graphic is a picture of three people talking.

FDA releases new biosimilars educational resources for patients

March 21 - New materials answer patient questions about biosimilars treatment options

Recent News

Graphic with text. Text reads CDER Small Business and Industry Assistance Generic Drugs Forum 2023 Celebrating 10 Years on April 12 and 13.

March 15 - Topics will focus on ANDA submissions, GDUFA III, IT updates and more

March 15 - Topics will focus on ANDA submissions, GDUFA III, IT updates and more
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CDER Designz

FDA offers strategies to mitigate drug shortages

March 13 - CDER expert explains challenges go beyond supply and demand issues
Office of New Drugs Research Program report cover
The Office of New Drugs Research Program was created in 2019 to foster regulatory science research.

Office of New Drugs releases two new Fiscal Year 2021 reports

March 3 - Reports summarize extramural research and ORISE fellowship outcomes

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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CDER’s ARC Program drives scientific and regulatory innovation and engagement to accelerate the availability of treatments for patients with rare diseases.

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

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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