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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

Guidance for Industry

FDA issues new draft ICH guidance for Good Clinical Practice

June 6 - Guidance ensures participant safety and reliability of clinical trials
Guidance for Industry

FDA issues guidance on adjusting for covariates in clinical trials

May 31 - These recommendations can improve detection of treatment effects
PMI ProposedRule

FDA releases proposed rule for Patient Medication Information

May 30 - Rule ensures patients receive essential prescription drug information

Recent News

CDER Small Business and Industry Assistance Webinars www.fda.gov/CDERSBIALearn

FDA to provide overview about guidance on decentralized clinical trials

May 30 - Will look at trial design, use of digital health technologies and more
Man lays in a hospital bed connected to ventilator looking up at nurses in blue scrubs and personal protective equipment

New therapy for pneumonia caused by certain difficult-to-treat bacteria

May 24 - Acinetobacter tops lists of urgent threats needing treatment options
CDER Small Business and Industry Assistance Webinars www.fda.gov/CDERSBIALearn

FDA to discuss the role of food effect studies in drug development

May 24 - Will cover study design considerations and the assessment of food on 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
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
Zebra against a blue background with a yellow arch in the back
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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@FDA_Drug_Info

Your source for the latest drug information.
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