FDA requires COVID-19 antibody test authorization from commercial manufacturers

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(CNN) – The Food and Drug Administration (FDA) is now requiring makers of COVID-19 antibody tests to seek emergency-use authorization.

The agency’s goal is to rein-in fraudulent tests that have flooded the market.

Commercial manufacturers must submit emergency authorization requests and validation data for their tests within 10 business days.

The policy shift, announced Monday, reverses one that the FDA instituted in March that loosened approval standards.

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