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  5. Overview of our role regulating and approving drugs | Video series
  1. Information for Consumers and Patients | Drugs

Overview of our role regulating and approving drugs | Video series

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

What is FDA’s role in regulating drugs?

We oversee prescription, generic, biosimilars, and over-the-counter drugs. But what is our role when it comes to drug regulation? 

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How does the FDA approve new drugs?

Prescription drugs go through many steps and phases before they’re approved by us. What does this process look like from beginning to end?

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What does the FDA do after drugs are approved?

Based on real-time information we receive from patients, drug manufacturers, and healthcare professionals, we may make recommendations to update the drug labeling. 

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