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FDA Doubles Test Review Staff, Is Prioritizing EUA Reviews For Home-Use And High-Batch Tests

 
• By Elizabeth Orr

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 that are 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 device center’s Office of In Vitro Diagnostics and Radiological Health, said during a 10 June...

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More from Policy & Regulation

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