The FDA’s Experience with Covid-19 Antibody Tests
Written by newsfeed
In January 2020, the Food and Drug Administration (FDA) began considering the U.S. response to Covid-19. On February 4, after the declaration of a public health emergency, we began authorizing tests to diagnose active infections. In such an emergency, the FDA can grant an emergency use authorization (EUA) for medical products on the basis of a review of the scientific evidence. Applying the lower EUA standard rather than waiting to grant full approval on the basis of more extensive evidence expedites access to accurate tests.