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Ready, Set, Go: ‘Unprecedented’ FDA Guidance Aims To Unburden Coronavirus Test Makers, Speed Process

The US agency issued a guidance document that significantly lowers regulation of diagnostics used specifically to fight the ongoing COVID-19 pandemic. The new policies give states far more autonomy, allow diagnostics makers to distribute products before an Emergency Use Authorization is issued by the FDA, and permits certain serological tests on the market if they adhere to proper labeling.

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The US Food and Drug Administration has published an “unprecedented” guidance that allows speedier access to diagnostic tests for COVID-19. The new policies will give states more autonomy in overseeing such tests, allow some tests on the market without Emergency Use Authorization (EUA) and relaxes regulations on serological tests.

The agency released an emergency guidance late in the day on 16 March that FDA commissioner Stephen Hahn said drastically changes agency policies regulating diagnostic tests for the novel...

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