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FDA Publishes Final Guidance For Developers Seeking EUAs For Monkeypox Tests, Grants First Approval To Quest

 
• By Brian Bossetta

The US FDA has issued guidance on its current thinking on enforcement policies for EUAs on monkeypox diagnostics, along with recommendations to help developers get their tests approved more quickly.

Monkeypox Test Tube
• Source: Shutterstock

In an effort to ramp up monkeypox testing, the US Food and Drug Administration issued a final guidance document outlining the agency’s thinking on emergency use authorizations (EUAs) on diagnostics to detect the virus.

The guidance, which the agency published 7 September, also provides developers with voluntary templates to use when validating their...

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