Monday, September 21, 2020 7:09:07 PM
One holdup might be...
There are hundreds of pre-EUA and EUA requests for COVID-19 tests under review and FDA continues to receive new submissions on a daily basis. To address this high volume of work, we have brought in additional scientific review staff to double the number of teams working on submissions; and we have implemented a triage program to prioritize submissions based on several factors. As a result of these efforts, by June 1, 2020, FDA had authorized over 125 diagnostic and serological tests, far exceeding the number of test EUAs issued during previous emergencies.
I do not understand why this has not advanced since Aug.: COVI-TRACE™ Diagnostic Test
FDA Emergency Use Authorization (EUA) Application Expected
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