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FDA ‘Stands Ready’ To Fight Coronavirus Via Emergency-Use Test Kits While WHO Mulls Virus Spread, Gets Out Guidance

 
• By Sue Darcey

The US Food and Drug Administration (FDA) stands poised to proceed with hastened approvals for 2019-coronavirus (nCoV) diagnostics, treatments and vaccines, if a public health emergency is declared, after an infected US traveler who caught the disease in Wuhan, China returned from the province to Washington State. Spread of the disease has reached a crisis level in China, and the World Health Organization met on 22 and 23 January to consider what actions to take to contain the virus, while issuing an interim laboratory test guidance for use in diagnosing the disease.

Coronavirus disease and flu outbreak or coronaviruses influenza background as dangerous viral strain case as a pandemic medical health risk concept with dangerous cells as a 3D render

The World Health Organization (WHO) is keeping an eye out for spread of a new coronavirus from Wuhan province in China to other countries, while the US Food and Drug Administration has readied plans for hastened emergency-use approvals of coronavirus test kits after an infected US citizen returned to Washington State from Wuhan.

The FDA would begin using its Emergency Use Authorization (EUA) process to clear the test kits, should the US Department of Health and Human Services (HHS) declare a public-health...

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