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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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COVID-19 Updates

Woman sorting pills at drug manufacturing plant.
New guidance provides clarity for regulated drug facilities during COVID-19 pandemic .

FDA issues guidance on conducting remote interactive evaluations

New guidance provides clarity for regulated drug facilities during COVID-19 pandemic

Asian woman doctor reads iPad in her office near a window.
Guidance describes how FDA will request and conduct remote interactive evaluations at facilities.

Guidance for Industry Document: Remote Interactive Evaluations

The FDA is issuing the guidance to describe how it will request and conduct evaluations

A senior woman holds a smartphone while attentively listening as a female doctor discusses her health.
Attentive patient listening to healthcare professional.

Know your treatment options for COVID-19

The FDA approved one drug and many more are being tested in clinical trials

Recent News

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FDA works to advance complex generic product development

May 4 - Complex generics may help patients get more affordable medicines
Small Business and Industry Assistance Webinars Text

FDA to provide overview of Study Data Technical Rejection Criteria

May 4 - Will discuss effective date, warning metrics, resources and FAQs
Pharmacometrics Models Impact Story Text on Blue Background

CDER scientists develop new approach to pharmacometrics

May 3 - Uses recurrent neural networks to model drug exposure and response

Navigate the Drugs Section

Trending Topics

Young woman with protective mask reading label on hand sanitizer bottle while in the supermarket during pandemic.
Woman wearing face mask while buying hand sanitizer in the store.

Q&A for Consumers | Hand Sanitizers and COVID-19

Learn how the FDA and its partners are addressing the COVID-19 outbreak
Senior adult woman measuring blood pressure at home.
Grandmother is measuring her blood pressure in the living room.

High Blood Pressure–Understanding the Silent Killer

It can lead to many serious problems that’s why it’s important to know your risk factors

Person Using Cell Phone in a Pharmacy

BeSafeRx: Your Source for Online Pharmacy Information

Explore resources and tools so you can safely buy prescription medicines online

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

Industry

Search drug databases, find guidances, or get small business assistance

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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