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FDA reverses policy that let over 100 antibody tests on market without review
Posted by: Steve G.
Date: May 05, 2020 06:56PM
The corollary to: ''Anybody who wants a test gets a test"
-both phonies


FDA reverses policy that let over 100 antibody tests on market without review
[www.politico.com]

The Food and Drug Administration is walking back a widely criticized policy that allowed more than 100 coronavirus antibody tests on the market without agency review.

Manufacturers of antibody tests must now apply for emergency use authorization within 10 business days after their products hit the market, under a policy announced Monday. If a test does not meet the FDA's specificity and sensitivity criteria, its manufacturer must suspend distribution.

Antibody tests can reveal whether a person has ever been infected by the coronavirus — identifying previously undetected cases and improving estimates of the overall size of the U.S. outbreak. The specificity of a test measures how often it correctly produces positive results, while sensitivity measures how often a test correctly produces negative results.

The FDA's decision to put into place stricter rules for antibody tests follows a congressional investigation launched by Rep. Raja Krishnamoorthi (D-Ill.), chairman of the House Oversight Economic and Consumer Policy Subcommittee. The FDA’s former policy allowed companies to validate their own tests and bring them to market without an agency review, if they included a disclaimer with test results.

A senior FDA official told POLITICO the policy change was not a direct result of pressure from Congress. Instead, the official said that having a dozen authorized tests on the market was a natural inflection point to reevaluate the agency’s approach to oversight. FDA Deputy Commissioner Anand Shah and device center chief Jeffrey Shuren wrote in a blog post Monday that the agency is aware of several commercial tests that are “being promoted inappropriately, including for diagnostic use.”

“Some test developers have falsely claimed their [antibody] tests are FDA approved or authorized,” Shah and Shuren wrote. “Others have falsely claimed that their tests can diagnose COVID-19 or that they are for at-home testing, which would fall outside of the policies outlined in our March 16 guidance, as well as the updated guidance.”
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Re: FDA reverses policy that let over 100 antibody tests on market without review
Posted by: sekker
Date: May 05, 2020 11:01PM
About time. This was terrible.
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Re: FDA reverses policy that let over 100 antibody tests on market without review
Posted by: Speedy
Date: May 05, 2020 11:36PM
Quote
Steve G.
The cor.ollary to: ''Anybody who wants a test gets a test"
-both phonies

Akin to, “If you like your doctor, you can keep your doctor.” Except now people are dying by the tens of thousands.



Saint Cloud, Minnesota, where the weather is wonderful even when it isn't.
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Re: FDA reverses policy that let over 100 antibody tests on market without review
Posted by: AllGold
Date: May 06, 2020 12:33AM
Quote
Speedy
Quote
Steve G.
The cor.ollary to: ''Anybody who wants a test gets a test"
-both phonies

Akin to, “If you like your doctor, you can keep your doctor.” Except now people are dying by the tens of thousands.

At the risk of stating the obvious... not at all the same. Trump was lying like he always does. For Obama, that was the intent.



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Re: FDA reverses policy that let over 100 antibody tests on market without review
Posted by: Speedy
Date: May 06, 2020 03:31AM
Quote
AllGold
Quote
Speedy
Quote
Steve G.
The cor.ollary to: ''Anybody who wants a test gets a test"
-both phonies

Akin to, “If you like your doctor, you can keep your doctor.” Except now people are dying by the tens of thousands.

At the risk of stating the obvious... not at all the same. Trump was lying like he always does. For Obama, that was the intent.

Not only the intent, but it was mostly true. I kept my doctor and so did everyone I know.



Saint Cloud, Minnesota, where the weather is wonderful even when it isn't.
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Re: FDA reverses policy that let over 100 antibody tests on market without review
Posted by: Lux Interior
Date: May 06, 2020 07:12AM
Quote
Speedy
Quote
AllGold
Quote
Speedy
Quote
Steve G.
The cor.ollary to: ''Anybody who wants a test gets a test"
-both phonies

Akin to, “If you like your doctor, you can keep your doctor.” Except now people are dying by the tens of thousands.

At the risk of stating the obvious... not at all the same. Trump was lying like he always does. For Obama, that was the intent.

Not only the intent, but it was mostly true. I kept my doctor and so did everyone I know.

And the obvious "if it meets the ACA requirements," i.e. isn't a crap plan that provides little useful coverage, that he failed to add.

And then granted waivers so people could even keep the crap plans.
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Re: FDA reverses policy that let over 100 antibody tests on market without review
Posted by: Lemon Drop
Date: May 06, 2020 08:06AM
I just had the antibody tests done Friday. Both negative. Gor results in 24 hours. My insurance says they cover it but I don't know if the lab got their test FDA approved. Anybody can get the test, you don't have to have symptoms. Mine was ordered by a physician but you can get it directly from the lab without a doctor's order.
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Re: FDA reverses policy that let over 100 antibody tests on market without review
Posted by: pdq
Date: May 06, 2020 08:44AM
Is it any surprise to anyone that when the normal constraints are lifted, the grifters and hucksters are the first to rush out and take advantage?

It’s almost as though there is a reason that all those horrible regulations and laws exist.
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Re: FDA reverses policy that let over 100 antibody tests on market without review
Posted by: Lew Zealand
Date: May 06, 2020 12:40PM
Quote
pdq
Is it any surprise to anyone that when the normal constraints are lifted, the grifters and hucksters are the first to rush out and take advantage?

It’s almost as though there is a reason that all those horrible regulations and laws exist.

NAAAAAH!

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Re: FDA reverses policy that let over 100 antibody tests on market without review
Posted by: wave rider
Date: May 06, 2020 02:19PM
Quote
Lew Zealand
Quote
pdq
Is it any surprise to anyone that when the normal constraints are lifted, the grifters and hucksters are the first to rush out and take advantage?

It’s almost as though there is a reason that all those horrible regulations and laws exist.

NAAAAAH!


NO TOUCH FACE!!!



=wr=
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