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vinovista

10/25/21 6:53 PM

#95869 RE: vinovista #95868

HHS said in a statement that as part of the new program, government health experts will conduct studies on over-the-counter tests and work with the companies “to compile proper data, work towards the right benchmarks for performance and support other needs that will help ensure they are providing the best submissions possible for FDA’s regulatory review.”

The U.S. Food and Drug Administration is streamlining its authorization process, while the National Institutes of Health will spend $70 million on a new program to accelerate test-makers through those regulatory hurdles. The funds will come from the American Rescue Plan, the $1.9 trillion Covid relief package President Joe Biden signed into law in March.
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IPwatcher

10/26/21 10:41 AM

#95870 RE: vinovista #95868

You are correct. they didn't mention any of the hundreds of test kits that are waiting for approval



That does not include DECN. DECN have never submitted an EUA or any completed request for approval to the FDA.
The only FDA authorization that DECN actually has is the one they inherited from Shasta, and which covers some obsolete blood glucose test strips. Zero evidence of a single medical device anywhere being taken through an FDA process BY DECN as yet.
And we know from court proceedings that FDA for Genviro was never actually submitted....
All they have is a computer generated autoreply!
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loanranger

10/26/21 11:19 AM

#95871 RE: vinovista #95868

Where can I get one of them GenViro! Covid-19 Saliva Swift Kits?