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Trump administration limits FDA review of some coronavirus tests

Rogue Valley

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Trump administration limits FDA review of some coronavirus tests

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8/19/20
The Trump administration will allow coronavirus tests developed by individual laboratories — including commercial facilities run by Quest Diagnostics and LabCorp — to be used without an FDA review, a decision that public health experts warn could lead to broad use of flawed tests. The Department of Health and Human Services outlined the decision in a notice published Wednesday. The majority of coronavirus tests used now in the U.S. are made by device manufacturers, who still must seek FDA permission to market their products. But the lab-developed tests affected by the new policy are also in wide use.The policy change has been a major point of tension for weeks between HHS and FDA, according to sources familiar with the debate.

For decades, most LDTs were relatively simple and available on a limited basis, so the FDA did not require them to undergo review. But the tests are now increasingly used to diagnose serious or life-threatening diseases or conditions that can affect public health decision-making — including the coronavirus — leading the agency to take a stronger regulatory stance. FDA’s website still says that during an emerging infectious disease outbreak, the tests "should not be used for clinical diagnoses without FDA’s approval, clearance, or authorization."

In their blind rush to develop faster COVID tests, the Trump administration (HHS) is now cutting safety corners by excluding the Federal Drug Administration (FDA).
 

CaughtInThe

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HIP56948

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Christ..sounds like we're back at the theater to watch "The exciting adventures of Lysol and Clorox #2 !" You'll be amazed at the results! Who is in charge of THIS round now? The My Pillow Man?
 
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snakestretcher

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This is not only stupid but potentially dangerous. I doubt the FDA will take this lying down. It will backfire on Trump.
 
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