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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

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

Guidance for Industry

FDA issues draft guidance on confirmatory evidence of clinical trials

Details use of data to support single clinical investigation results

Recent News

Women screaming into a megaphone next to the word alert

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

Therapeutic equivalence code changed for Accord’s tacrolimus
Division of Drug Information CE Webinar for health care professionals on September 23rd, 2023

New webinar on FDA’s regulatory framework on human drug compounding

Provides an overview of human compounding and the regulatory process
Close up image of a pile of prescription pill bottles with pills in them

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

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
Two young women hugging while at home.
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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