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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's ISTAND Pilot Program accepts new submission

Submission is first AI-based and digital health technology-based project
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Osteoporosis drug Prolia increases the risk of severe hypocalcemia

Patients on dialysis or with mineral and bone disorder at highest risk
Blue capsules on conveyor at modern pharmaceutical factory.

New webpage for searching pharmaceutical quality resources

Page improves access to relevant and up-to-date resources and information

Recent News

New Drug Therapy Approvals 2023 Report Cover

FDA publishes annual report highlighting new drug approvals

Illustrates CDER’s role in advancing health through innovation
White graphic with text overlay reading Drug Safety Communications. On the left side of the graphic is an image of multi-colored pills.

FDA evaluating risk of suicide with diabetes and obesity drugs

Preliminary results do not suggest a causal link
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FDA approves promethazine hydrochloride injection labeling updates

Changes mitigate risk of irritation and tissue damage

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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@FDA_Drug_Info

Your source for the latest drug information.
Know the moment it happens.

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