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December 18, 2020 07:25 pm

Whats the difference between FDA approval and authorization?




Photo of a sign outside a large building that reads “US Department of Health and Human Services, Food and Drug Administration”
FDA headquarters in Maryland. | Photo by Sarah Silbiger/Getty Images



In most contexts, it’s perfectly acceptable to use “approval” and “authorization” interchangeably. But not at the Food and Drug Administration (FDA), and definitely not when it comes to COVID-19 vaccines. If the topic comes up at your Zoom holiday party, here’s a cheat sheet for the specific uses of these similar terms.


Approval — No COVID-19 vaccines have been approved. Approval means the FDA has officially decided that a product is safe and effective for its designated use. The process for approval involves rigorous reviews of all available data on the product and can take several months.


Authorization — To speed things up in an emergency like a pandemic, the FDA can grant an Emergency Use Authorization (EUA). An EUA, as its name...



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Original Link: https://www.theverge.com/22189236/fda-approval-authorization-difference-clearance-vaccines

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