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Posted On: 03/16/2021 7:10:47 PM
Post# of 22461
Progress! I see that statement as a softening slightly of their rigid standings to accommodate Biden. That statement makes me think that 'ease of use' might be a mitigating consideration when analyzing hard test data for approving a home test.
Note that the FDA hinted at this policy around Feb 9 when it said -
Asked about the Innova application, Shuren, the FDA official, responded broadly, emphasizing the need for solid data. "We consider tests for at-home use to be a top priority,” he said. “And if they've got their data and the data looks good, we authorize."
To me, Feb 9 starts the clock when CITI might have started organizing its home test employee program, and it might be nearing completion. If the FDA is seeing favorable preliminary data, that might have been the reason for this notice.
Note that the FDA hinted at this policy around Feb 9 when it said -
Asked about the Innova application, Shuren, the FDA official, responded broadly, emphasizing the need for solid data. "We consider tests for at-home use to be a top priority,” he said. “And if they've got their data and the data looks good, we authorize."
To me, Feb 9 starts the clock when CITI might have started organizing its home test employee program, and it might be nearing completion. If the FDA is seeing favorable preliminary data, that might have been the reason for this notice.
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