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  5. Transcript | What is FDA's Role in regulating drugs?
  1. Information for Consumers and Patients | Drugs

Transcript | What is FDA's Role in regulating drugs?

Learn how we use science and data to ensure their safety, quality and efficacy

You may know the FDA is responsible for approving new drugs and making sure those drugs are safe, high quality, and work the way they’re supposed to. 

But HOW is it done? How are decisions made, and are those decisions in your best interest? What else does the FDA do--and NOT do?

These are important questions! And the FDA understands the importance of asking and answering questions -- because that’s exactly what it does.  

The highly trained staff in the FDA’s Center for Drug Evaluation and Research are committed to protecting the public’s health, advancing science, and regulating human drugs.

These staff analyze data, evaluate research, and make decisions based on science to ensure that prescription, generic, biosimilars, and over-the-counter drugs work correctly. They use science and data to ask – and answer – questions like:

  • Is this new drug safe? 
  • Does it work the way it’s supposed to?
  • Do the benefits of this drug outweigh the risks?

And once drugs are approved, the FDA monitors them for safety and quality for years to come. 

This thorough analysis helps the FDA provide the timely information health care providers and patients need to choose treatments wisely.

The FDA’s decisions are not influenced by industry or politics. The FDA’s decisions are guided by science and data. 

It’s important to know that the FDA oversees clinical trials for safety and reviews the resulting data. However, the FDA does NOT conduct clinical trials. 

FDA also does NOT control the cost of drugs or get involved in interactions between patients and their health care providers.

As part of its public health mission, the scientists and staff at FDA work to protect the American public by getting the accurate, science-based information they need to use medications wisely. All by asking questions and letting science lead to the answers.

Questions about the FDA and human drugs? Find the answers at www.fda.gov/drugs.

Related information

Overview of our role regulating and approving drugs | Video series

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