How an Emergency Use Authorization (EUA) Works
An EUA may be issued by the FDA to allow access to critical medical products that may help during a public health emergency. An EUA is different from approval/licensure.
The following criteria must be met for an EUA to be issued:
- The product will be used for a serious or life-threatening disease or condition.
- Based on the totality of scientific evidence available, it is reasonable to believe the product may be effective.
- The known and potential benefits of the product outweigh the known and potential risks of the product.
- There is no adequate FDA-approved alternative available.
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FDA Guidance on EUA for Vaccines to Prevent COVID-19 |
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Page last reviewed: November 19, 2020
Content source: November 19, 2020