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FDA’s Authority to Regulate Lab Tests Is Curtailed

WSJ Original article ›
LyrArc Article Gist
Analysis of its findings in the WSJ story on August 18 shows the FDA unnecessarily delayed private labs from developing and using their own tests from Feb 9 when FDA test for coronavirus failed for its third component. The FDA said it would correct the flaws but repeatedly failed to do so until it finally allowed private labs to go ahead on their own- a costly delay of 3 weeks that made the test and contact trace strategy inoperable, because the time window was lost in those 3 critical weeks. In March through August the pandemic has now taken up about 5 million cases in the U.S. and 170,000 deaths, with no end in sight.

During times like these and in a swiftly moving current of a river such as the time of a pandemic, the  teaching hospital labs and labs with resources and scientific reputation with their lightning speed have to have the freedom  to immediately respond. In this case the FDA should have released the private labs of teaching hospitals and the the highly reputable labs of well known medical companies to immediately start developing their own tests and using them, starting  on Feb. 10 the day after it was evident that the FDA test's third component was not working.



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