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  5. Transcript | How does the FDA approve new drugs?
  1. Information for Consumers and Patients | Drugs

Transcript | How does the FDA approve new drugs?

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

When you reach for your prescription medications, you trust that the medicine is going to do what it’s supposed to do – make you feel better!

That trust comes from knowing that teams of doctors, biologists, chemists, pharmacists and other health scientists at the FDA are working tirelessly to protect the health of the American public by making careful, informed decisions about which new drugs to approve. 

So how does the FDA determine if a drug is safe and effective? 

It follows a comprehensive, multistep process that includes many steps and check points.  

First, a drug maker develops a drug to help treat a disease or medical problem, then they test it in a lab. 

If these preliminary tests go well, the drug maker fills out an Investigational New Drug Application and submits it to the FDA. This application explains how the drug maker plans to investigate and test the drug in clinical trials on volunteers. These clinical trials, which can take about 6 years to complete, must follow a set of laws and regulations that are meant to protect the rights, safety, and welfare of volunteers. 

There are typically three phases in a clinical trial, with each phase involving more patients. It’s important to remember that the FDA does NOT develop new therapies or conduct clinical trials; however, FDA DOES have rules to ensure they remain safe. 

Once the drug maker has conducted the clinical trials and has gathered enough data to show the drug is safe and effective, they can submit a New Drug Application to get that drug approved by the FDA. 

At this point, an unbiased team of FDA experts evaluates the clinical trial research and scientific data to determine if it meets FDA’s rigorous standards. The FDA asks questions like, is this drug safe? Does it work the way it should? Is it high-quality? Do its benefits outweigh its known risks? 

If the answers are yes, the FDA then inspects the facility where the drug will be made to make sure it meets the FDA’s standards for manufacturing. 

If the FDA team determines that the research, data, and evidence shows that the drug is safe and effective for the intended use, the FDA approves the drug. 

Once a drug is approved and patients begin taking it, the FDA continues to monitor the drug’s safety, effectiveness, and quality for years to come. 

The process to develop and then approve a medication can take several years; it’s a sign that the FDA is committed to protecting patients. So, the next time you pick up that prescription medication, you can trust that it’ll do what you need it to do, safely and effectively.  

Questions about the FDA or the clinical trials? Learn more at www.fda.gov/drugs.

Related information

Overview of our role regulating and approving drugs | Video series

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