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COVID-19: FDA Eases Approval Policy By Allowing LDT Use Under ‘Immediately In Effect’ Guidance

 
• By Sue Darcey

The US FDA on 29 February issued a new guidance giving the OK to labs with pending COVID-19 laboratory-developed tests (LDTs) to use them while they await the agency’s approval under Emergency Use Authorization. The agency issued the guidance quickly, taking the unusual step of forgoing a public comment period.

Nurse wearing respirator mask holding a positive blood test result for the new rapidly spreading Coronavirus, originating in Wuhan, China

The US Food and Drug Administration issued a new guidance on 29 February giving the OK to labs with pending COVID-19 laboratory-developed tests (LDTs) to use them while they await the agency’s approval under its Emergency Use Authorization (EUA).

The agency’s new coronavirus test policy – in the form of Immediately in Effect FDA Guidance for Clinical Labs...

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More from Policy & Regulation

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With LDT Rule DOA, Could FDA Shift Focus To RUOs?

 
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