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FDA Officials: Serology COVID-19 Tests Should Be Pre-Authorized

By Kelly Lienhard / February 16, 2021 at 5:31 PM
Top FDA device center officials over the weekend acknowledged early agency missteps in regulating COVID-19 serology tests and said moving forward the government should not let serology tests enter the market unless they are authorized by FDA. FDA device center head Jeff Shuren and diagnostics shop director Timothy Stenzel proposed five steps the federal government should take to ensure the availability and accuracy of antibody testing in future national health emergencies, in a Saturday (Feb. 13) New England Journal of...


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