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FDA Boosts Development Of OTC COVID-19 Tests With New Template

 
• By Elizabeth Orr

A new template from the US FDA explains what information the agency wants to see in regulating COVID-19 tests to be performed outside the laboratory environment.

Washington, D.C., USA- January 13, 2020: FDA Sign outside their headquarters in Washington DC. The Food and Drug Administration (FDA or USFDA) is a federal agency of the USA.

Diagnostics companies working on tests for the novel coronavirus that could be distributed over the counter got fresh guidance on 29 July, as the US Food and Drug Administration released a new template that shows what emergency use authorization (EUA) submissions for these tests might look like.

The template addresses the design and development of COVID-19 diagnostic tests that can be performed entirely at home or in...

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