What is the criteria for an EUA?

  • The FDA may issue an EUA for a medical product if it meets the following criteria:
    • The disease or CBRN agent in question can cause a serious or life-threatening illness or condition. 
    • There is reasonable belief, after looking at all the scientific evidence, that the product may be effective for its intended use. The phrase “may be effective” lowers the standards for scientific evidence typically required for FDA approvals.
    • The known and potential benefits outweigh the known and potential risks. The FDA will look at all available scientific evidence to determine the risk and benefits of a product. 
    • There is no adequate, approved, and available alternative to the product.

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