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Too many rules? FDA restricts coronavirus at-home test kits
Fox News ^ | March 30 2020 | Maxim Lott | Fox News

Posted on 04/16/2020 10:29:43 AM PDT by rintintin

The Food and Drug Administration (FDA) is under fire for being too slow to approve at-home tests in the coronavirus crisis.

Earlier this month, the agency announced it would allow labs to sell tests, and apply for emergency approval 15 days later. Several companies jumped to offer their tests in a use-at-home format, and some even began selling them.

Most of the tests were to be taken by an individual at home, and then would be mailed to an approved lab for analysis – a process already used for many medical tests.

But on March 20, the FDA updated their guidance, saying their regulatory waivers "do not apply to at-home testing, including self-collection of samples to be sent to a clinical laboratory."

That forced the companies offering at-home tests to immediately shut down sales.

Ten days later, no at-home kits have been approved by the FDA. The FDA defended its action and said it wants to ensure tests are accurate

“It is critical to ensure that home collection and transport of specimens to labs still provide for accurate test results,” an FDA spokesperson told Fox News by email.

But critics say the approach is too cautious.

(Excerpt) Read more at foxnews.com ...


TOPICS: Business/Economy; Culture/Society; Government
KEYWORDS: athometest; chinavirustest; fda

1 posted on 04/16/2020 10:29:43 AM PDT by rintintin
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To: rintintin

The liberal lefty liberal fascists control FDA. I have no dopount about that now. They WANT a long game.


2 posted on 04/16/2020 10:32:58 AM PDT by Candor7 (Obama Fascism:https://www.americanthinker.com/articles/2009/05/barack_obama_the_quintessentia_1.html)
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To: rintintin

Trump size twelve needs to be firmly and violently placed.


3 posted on 04/16/2020 10:33:28 AM PDT by AndyJackson
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To: rintintin

4 posted on 04/16/2020 10:34:31 AM PDT by amorphous
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To: rintintin

But we can talk to a doctor on-line and obtain prescriptions...just by “informing them of what’s ailing us” ... go figure.


5 posted on 04/16/2020 10:35:37 AM PDT by trebb (Don't howl about illegal leeches, or Trump in general, while not donating to FR - it's hypocritical.)
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To: trebb
But we can talk to a doctor on-line and obtain prescriptions...just by “informing them of what’s ailing us” ... go figure.

And we can walk into any pharmacy and get injected with a vaccine WITHOUT a doctor's prescription.

6 posted on 04/16/2020 10:38:45 AM PDT by Shethink13 (there are 0 electoral votes in the state of denial)
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To: trebb

Perhaps they’re afraid that people doing this at home are going to screw it up and they’ll get a lot of false results?

Cause the one thing we really don’t need in all this is even more fake data.


7 posted on 04/16/2020 10:39:01 AM PDT by Buckeye McFrog (Patrick Henry would have been an anti-vaxxer)
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To: rintintin

Is it possible to ignore the FDA?


8 posted on 04/16/2020 10:40:08 AM PDT by Wm F Buckley Republican
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To: rintintin

They think everyone is stupid except them.


9 posted on 04/16/2020 10:41:47 AM PDT by DivineMomentsOfTruth ("There is but one straight course, and that is to seek truth and pursue it steadily." -GW)
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To: Buckeye McFrog

Not to mention are people going to do a good job sealing the kit before sticking in the mail? Last thing we need is a bunch of infected snot moving around the country by mail.


10 posted on 04/16/2020 10:44:19 AM PDT by discostu (I know that's a bummer baby, but it's got precious little to do with me)
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To: Wm F Buckley Republican

Whether ‘their’ fault or not, isn’t CDC/FDA/WHO the ones that led us into this abyss to start with.

SO, we sit back and wait for ‘advice’ from the people that ‘blew it’ to begin with????

Sort of like a driver tries to drive through a snow bank and when the wrecker gets there bothers everyone with how to get it out???

YOU did your job by ‘crashing’ your vehicle, now get out of the way and let me bail you out.


11 posted on 04/16/2020 10:44:53 AM PDT by xrmusn (6/98"HRC is the Grandmother that lures Hansel & Gretel to the pot")
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To: Buckeye McFrog

No, they’re just afraid people will wake up to the fact that in the day of the internet, and free exchange of information, the only one who needs them is big pharma - that and they’re afraid people may learn the FDA is responsible for more human tragedy (both in lives and fortunes lost) than any virus.


12 posted on 04/16/2020 10:47:23 AM PDT by amorphous
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To: Buckeye McFrog
Agreed - was just doing what I'm so prone to do and making a "can you believe it" quip....one of my major faults and happiest pastimes.

It seems that the self-contained tests should be fairly reliable as a finger on the pulse deal, while the lag time between mailing a sample (of a potential contagion) may add to the confusion chaos ... and tell someone who picked the bug up in the interim that they are A-OK.

I suppose there's pluses and minuses to the process...not to mention current availability and people's propensity for buying fake products on-line...

I wonder if the on-line doctors can prescribe HCQ...while prescription drugs are controlled substances, there's also a whole other line of CONTROLLED substances

13 posted on 04/16/2020 10:52:04 AM PDT by trebb (Don't howl about illegal leeches, or Trump in general, while not donating to FR - it's hypocritical.)
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To: discostu

All medical testing has a chain of custody.
I’m not a professional but I know that much.


14 posted on 04/16/2020 11:07:10 AM PDT by Buckeye McFrog (Patrick Henry would have been an anti-vaxxer)
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To: rintintin

This is the corrupt organization that STOPPED
the making of HCQ in the USA.

why?

who?

are they still there?

who?

why?


15 posted on 04/16/2020 11:09:51 AM PDT by Diogenesis ( WWG1WGA)
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To: rintintin

there should be cheap CV-19 and flu tests for home.

There are home flu tests > $300.


16 posted on 04/16/2020 11:25:26 AM PDT by DannyTN
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To: Buckeye McFrog

Yeah. Then there’s the hypochondriac problem. My boss would get a hold of a bunch of tests and test himself daily.


17 posted on 04/16/2020 11:32:21 AM PDT by discostu (I know that's a bummer baby, but it's got precious little to do with me)
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To: rintintin

Swamp never drained! The Swamp is running most of government and President Trump stands alone in the middle as we are on the shores.


18 posted on 04/16/2020 11:36:06 AM PDT by shanover (...To disarm the people is the best and most effectual way to enslave them.-S.Adams)
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To: discostu

Good point.

Which is why I argue that the idea of antibody testing all of us is pointless.

Say I test positive and can return to work.
Say you test negative and can not.
You need to earn an income.
What are you going to do?

You are going to go out and get yourself deliberately infected so that you can recover and test negative.

You and 100 million of your closest friends.

Which renders this entire lockdown moot and stupid.

Government utopians never account for how people ACTUALLY behave in the real world.


19 posted on 04/16/2020 11:44:17 AM PDT by Buckeye McFrog (Patrick Henry would have been an anti-vaxxer)
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To: Buckeye McFrog

Yeah. I’m with you. As soon as we start using the antibodies as a return people will be infecting themselves.


20 posted on 04/16/2020 11:50:56 AM PDT by discostu (I know that's a bummer baby, but it's got precious little to do with me)
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