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The FDA Updates Templates for Serology EUA Requests

Wednesday, July 1, 2020   (0 Comments)
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The FDA Updates Templates for Serology EUA Requests

The U.S. Food and Drug Administration (FDA) updated the templates for laboratories and commercial manufacturers to help facilitate submission of Emergency Use Authorization (EUA) requests for serology tests.The updates clarify FDA’s previous recommendations for demonstrating clinical performance and presenting validation data, and provide new recommendations for validation of point-of-care tests.

 

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