FDA Prioritizes Emergency-Use Reviews For Coronavirus At-Home Tests, Doubles Review Staff

A top FDA official said the agency has more than doubled its virology review staff to handle the cascade of EUA applications. He said the agency is prioritizing certain COVID-19 diagnostics during a recent webinar.

Coronavirus

COVID-19 diagnostics intended for home use and those that allow for processing large sample batches are being prioritized by the US Food and Drug Administration review staff, according to an agency official.

Timothy Stenzel, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA's Center for Devices and Radiological Health, said during a 10 June webinar that reviewers in the virology department have been seeing about 60 times more emergency use authorization (EUA) submissions than

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