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

Executive Summary

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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