FDA will no longer review EUAs for COVID-19 LDTs
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Posted On: 12/16/2020 5:23:31 PM
FDA will no longer review EUAs for COVID-19 LDTs
LABline
Oct 8th, 2020
The U.S. Food and Drug Administration (FDA) will no longer review emergency use authorization (EUA) requests for COVID-19 lab developed tests (LDTs). The agency outlined the change on its webpage FAQs on Testing for SARS-CoV-2, according to a press release.
“We are currently in a different phase of the pandemic with respect to tests than we were previously, where many COVID-19 tests are now authorized to be run in labs,” the agency wrote, adding that the “FDA is declining to review EUA requests for LDTs at this time.”
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Things will change in the next administration IMO.
LABline
Oct 8th, 2020
The U.S. Food and Drug Administration (FDA) will no longer review emergency use authorization (EUA) requests for COVID-19 lab developed tests (LDTs). The agency outlined the change on its webpage FAQs on Testing for SARS-CoV-2, according to a press release.
“We are currently in a different phase of the pandemic with respect to tests than we were previously, where many COVID-19 tests are now authorized to be run in labs,” the agency wrote, adding that the “FDA is declining to review EUA requests for LDTs at this time.”
--
Things will change in the next administration IMO.
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