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”

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...

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