
Federal officials knowingly allowed distribution of flawed antibody tests - enraged_camel
https://www.cbsnews.com/news/federal-officials-allowed-flawed-covid-19-antibody-tests-2020-06-25/?ftag=CNM-00-10aab7d&linkId=92064279
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vikramkr
After over-regulation of PCR tests leading to the flawed CDC test being the
only one available during a critical part of the pandemic, the agency decided
to swing way way way too hard the other way so they couldn't be accused of
holding up tests from reaching the market. This whole fiasco has revealed the
importance of modernizing the FDA (they still need documents to be sent by CDs
in the mail![1]). And, of proactively creating pandemic response protocols.
They're a healthcare agency! This is their job! The failure of the federal
government has been so profound. At least it'll make a good case study for
what not to do...

[1]
[https://www.washingtonpost.com/investigations/2020/04/03/cor...](https://www.washingtonpost.com/investigations/2020/04/03/coronavirus-
cdc-test-kits-public-health-labs/?arc404=true)

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gumby
Until only a few years ago, when you were ready to submit your NDA (new drug
application — afterballnthe trials were concluded) you literally sent _trucks_
full of paper to the Agency. There were companies that specialized in making
that happen properly — you didn’t just hire a trucking company; a lot of
coordination was required.

I (well, my company but my name was signed on the documents and I did a lot of
work) filed one of the very last paper INDs (beginning of the process before
you even do Phase I). Honestly it was cheaper and simpler than purchasing one
of the special packages needed to do an electronic filing.

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gumby
There was a lot of pressure in March and April to authorize tests despite them
not being proven to have any reliability. Much complaint about the “hidebound
bureaucracy”. Apparently somebody listened to those clowns.

~~~
redis_mlc
This should be a lesson for fast-tracking corona vaccines, but we will
probably learn the hard way and turn the US into a nation of anti-vaxxers in
the process.

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enraged_camel
I had to edit the headline because the original didn't fit.

