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Posted On: 12/19/2020 11:09:18 AM
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HHS Instructs FDA to Resume Review of EUA Submissions for SARS-CoV-2 LDTs
Nov 17, 2020 | Adam Bonislawski
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NEW YORK – On a media call Monday, Brett Giroir, assistant secretary for health at the US Department of Health and Human Services, said that he had formally instructed the Food and Drug Administration to review voluntary Emergency Use Authorization submissions of SARS-CoV-2 lab-developed tests.
The instructions reverse a previous FDA decision to no longer review EUA submissions for SARS-CoV-2 LDTS, but a number of questions remain about how broadly they will be applied and how exactly they will be implemented.
https://www.360dx.com/regulatory-news-fda-app...94lFthKiUn
Nov 17, 2020 | Adam Bonislawski
Premium
NEW YORK – On a media call Monday, Brett Giroir, assistant secretary for health at the US Department of Health and Human Services, said that he had formally instructed the Food and Drug Administration to review voluntary Emergency Use Authorization submissions of SARS-CoV-2 lab-developed tests.
The instructions reverse a previous FDA decision to no longer review EUA submissions for SARS-CoV-2 LDTS, but a number of questions remain about how broadly they will be applied and how exactly they will be implemented.
https://www.360dx.com/regulatory-news-fda-app...94lFthKiUn
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