How Does FDA Approval Work?


Before a new drug can land on pharmacy shelves, it must be FDA-approved. Learn how that happens.

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DR. RODGERS: Did you know that the U.S. has the safest and most advanced drug approval process in the world?

Hi, I’m Dr. Griffin Rodgers, director of the National Institute of Diabetes and Digestive and Kidney Diseases at NIH.

My colleague, Captain Richardae Araojo, of the U.S. Food and Drug Administration, or FDA, explains:

MS. ARAOJO: Before a new drug can land on pharmacy shelves, it must be approved by FDA. After a drug company discovers a new drug, then it is tested for safety, quality, and effectiveness. This includes testing in clinical trials to show if the health benefits outweigh the risks for its intended use. The FDA reviews all of this information before a product is approved. After approval, FDA monitors the product for safety and the drug company must submit regular safety updates.

This process makes sure that a drug is safe and effective for its approved uses.

DR. RODGERS: For more information on the FDA drug approval process, follow us on Twitter @NIDDKGov. This is Dr. Griffin Rodgers with the NIH.

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