FDA Releases New Tools to Speed COVID-19 Test Development

The US agency on 29 May gave two additional tools to COVID-19 test developers: an emergency use authorization template for tests using at-home sample collection kits, and a reference panel for the disease.

FDA entrance sign 2016

Diagnostics firms developing tests for the novel coronavirus got two new tools from the US Food and Drug Administration on 29 May, as the agency released an emergency use authorization (EUA) template for tests using at-home sample collection kits, as well as a COVID-19 reference panel.

The voluntary EUA template makes recommendations for labs and commercial manufacturers hoping to submit EUA requests for molecular diagnostics...

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