1/n The large clinical labs are a great national asset and have an important role to play in responding to public health emergencies like #coronavirus. These policy accommodations can help them advance this important mission.
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2/n The regulatory path for labs that start
#coronavirus testing and seek EUA could be flexible, taking account of the expertise and good processes that these high complexity labs have in developing tests.1 reply 6 retweets 31 likesShow this thread -
3/n The EUA process should be efficient for labs that follow FDA’s guidance to develop well validated tests and have strong controls. FDA can make templates and common protocols available to help labs working through the process for the first time.
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Replying to @ScottGottliebMD
No hope for getting em from the CDC eh?
3:06 PM - 4 Mar 2020
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