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BioWorld - Sunday, December 21, 2025
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Home » FDA tightens EUA submission deadline to 10 days for COVID-testing
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FDA tightens EUA submission deadline to 10 days for COVID-testing

May 4, 2020
By Mark McCarty
The FDA has revised its emergency use authorization (EUA) policy for testing for the COVID-19 pandemic, the impact of which falls principally on serological tests for antibodies generated by the SARS-CoV-2 virus. The agency had previously allowed a commercial antibody test developer to distribute a test without submitting the validation data, but makers of such tests now must forward the validation data to the FDA within 10 days, a move prompted in part by inappropriate claims made by some test developers.
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