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Ex-FDA Commish Warns Of ‘Limbo’ For COVID-19 LDTs Granted Emergency Use Authorization

Gottlieb cautions in tweets that a new policy by the HHS to remove FDA oversight of lab developed tests “is broader than COVID. It covers any LDT”

 
• By Shawn M. Schmitt

Scott Gottlieb took to Twitter on the morning of 22 August to question the wisdom of a move this past week by the US HHS to strip away the FDA’s oversight of laboratory developed tests for the novel coronavirus.

Scott Gottlieb

In a series of tweets on 22 August, former US Food and Drug Administration commissioner Scott Gottlieb questioned the wisdom of a recent move by the Department of Health and Human Services (HHS) to remove the FDA’s oversight of laboratory developed tests (LDTs) for COVID-19.

The HHS said on 19 August that LDT makers no longer need to notify the FDA before sending their diagnostics to market. The HHS noted that the agency won’t...

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