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U.S. Department of Health and Human Services

About FDA

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Drugs

FDA Basics 
 Image of a hand reaching for a pill bottle in a medicine cabinet

Over-the-counter and prescription drugs, including generic drugs, are regulated by FDA's Center for Drug Evaluation and Research (CDER). This work covers more than just medicines.

For example, fluoride toothpaste, antiperspirants, dandruff shampoos and sunscreens are all considered "drugs."

 

Do You Know…
How a New Prescription Drug is Approved?

Drug companies seeking FDA approval to sell a new prescription drug in the United States must test it in various ways. First are laboratory and animal tests. Next are tests in humans to see if the drug is safe and effective when used to treat or diagnose a disease. More…

FDA Basics Videos

John Jenkins 137x145

Watch a video about FDA's role in the development, testing, and monitoring of new drugs

John Jenkins, director of the Office of New Drugs in the Center for Drug Evaluation and Research, looks at changes in the way new drugs are evaluated. Watch FDA Basics Videos...

 

 
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