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this post was submitted on 30 Jan 2024
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FDA had denied, company presumably made some sort of changes that were not publicized (or paid off the right people), FDA approved.
If you’ve ever dealt with getting a medical device approved by the FDA, you’d know they don’t fuck around. They’re so hardcore it’s scary.
there are ways around them. convince them your product is "substantially equivalent" and they don't look too hard, apparently. (see - hard silicone penile implants)
https://www.propublica.org/article/penis-enlargement-enhancement-procedures-implants
They famously didn't approve the wonder drug thalidomide.
Not when you're the wealthiest person in the world. All hurdles are trivial when you're wealthy.
In my experience, I've seen a muti billion dollar company denied new product testing for errors on paperwork.
My former employer had to etch "not for human use" in the devices because the FDA didn't clear them. They took them to use on sheep instead.
The FDA, as long as it doesn't fall prey to the revolving door like every other regulator, is extremely effective.
I wouldn't say "effective". They're good at rejecting bad things, but they accomplish that largely by being very risk-averse. People who suffer because a treatment wasn't approved should count for more than they do. The best possible policy might be one that lets a few bad things through if it also lets through a lot more good things.
That's exactly what we would hear everytime we asked about the paperwork from the FDA authorizing human trials. I'm sorry, but it works.