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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

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

FDA to host virtual forum about the generic drug assessment program

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

CDER Conversation template with blue background and Emily Thakur photo.
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

Recent News

Graphic with an image in the upper left of human cells and an image in the bottom right of someone taking pills. There is text in the upper right that says, Drug Safety Priorities 2022.

CDER publishes its Drug Safety Priorities 2022 annual report

March 2 - Highlights safety efforts taken to help promote and protect public health
Graphic with blue background and white text. Title is Biosimilar Medications; the subtitle is Working to Help Advance Competition for Biosimilars and to Address Misleading Information. An icon of an IV bag and needle, as well as a pill bottle are to the left of the text.

CDER director describes government agencies work to promote biosimilars

March 2 - Goals are to spur competition, address false and misleading information
Office of Generic Drugs 2022 annual report cover
The Office of Generic Drugs (OGD) Annual Report provides a summary of OGD’s activities and accomplishments during the year.

CDER’s Office of Generic Drugs publishes 2022 annual report

March 1 - Highlights OGD’s drug approval efforts, COVID-19 work and more

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

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(855) 543-3784
(301) 796-3400

Hours Available

CDER Division of Drug Information

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