COVID-19: FDA Clarifies New Guidance, NCI Role

An official from the US agency focused on new coronavirus diagnostic guidance, testing for asymptomatic individuals, and a National Cancer Institute validation project in a recent teleconference.

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The US Food and Drug Administration’s recent decision to more closely regulate COVID-19 antibody tests has raised some concerns for industry, a recent virtual town hall hosted by the agency indicates.

The FDA updated its guidance on both diagnostic and antibody tests, also known as serological tests, on 4 May. Under the new guidance, antibody test manufacturers must submit validation data...

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