FDA EUA Speed of Review in 1st 9 month… More data on FDA & Volume of Covid tests they have reviewed and speed to approval.
It’s not a matter of months… more like days I believe, based on this data.
Since February 2020 through November 1, 2020 (9 months), the FDA used Emergency Use Authorization for over 285 diagnostic and serology Covid-19 tests. That’s 9 months X 21 average work days per month is 189-190 work days at 285 tests. That averages 1.5 per work day approved.
I doubt we have that much more time to wait.
Source: https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/covid-19-test-development-and-review-faqs-testing-sars-cov-2Q: I submitted a pre-EUA or EUA request for a COVID-19 test. How long will the review take? (Updated 11/16/20)A: During this unprecedented public health emergency, the Agency has received an exceedingly high volume of EUA requests and is working as quickly as possible to review each request. 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 November 1, 2020, FDA had authorized over 285 diagnostic and serology tests, far exceeding the number of test EUAs issued during previous emergencies.