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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

CDER Small Business and Industry Assistance Webinars Graphic

Learn about FDA’s BsUFA III Regulatory Science Pilot Program

We will discuss Roadmap 2.0 research priorities and ongoing projects

Center for Drug Research and Evaluation (CDER) conversation with Evan Wearne

CDER expert discusses prescription drug-use-related software

Software could help people take medication more safely, effectively
Center for Drug Evaluation and Research's Small Business and Industry Asistance (SBIA) is hosting a 2023 NanoDay Symposium on continuous manufacturing of nanomaterials on October 11th

Join us as FDA discusses continuous manufacturing of nanomaterials

Topics include case-studies of intramural and extramural research

Recent News

Guidance for Industry

FDA issues draft guidance on confirmatory evidence of clinical trials

Details use of data to support single clinical investigation results

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Accord’s generic organ rejection drug not substitutable for brand drug

Therapeutic equivalence code changed for Accord’s tacrolimus
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FDA releases FY22 GDUFA Science and Research Outcomes Report

Details support of program-funded initiatives for generic drug development

Navigate the Drugs Section

FDA Initiatives

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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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