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US FDA Describes Device Emergency Use Authorization Process In Draft Guidance

This article was originally published in SRA

Executive Summary

Companies or government agencies should tell the US Food and Drug Administration about any products in development that might address a brewing public-health emergency, even if the threat has not yet been officially declared by the government, the agency says. The goal is to accelerate an eventual emergency use authorization (EUA), which is the subject of April 4 draft guidance from FDA1.

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