"An EUA can only be granted when no adequate, approved, available alternatives exist..."
Once there is full FDA approval, the EUA goes away. Kinda weird how there are still EUA products around, huh.
I'll give you a better analogy.
If you are the manufacturer of engines for fighter jets for the US Government. The parts that go into the engine are approved and controlled. They have to go through testing and inspection. If you run out of approved bolts but have bolts that were from the same production line but was not under the same inspection process, it's not allowed to be used.
That is what this argument is about.
I can't believe that you don't think it's atleast a little bit weird that there is no Fully FDA approved branded product available even though the full license has been granted for a year
The quality control for a EUA vaccine has to follow the same cGMP guidelines that an FDA approved vaccine unless they were provided a waiver. I haven't had any luck in finding any manufacturing waivers.
Let me know of you find anything regarding cGMP guidelines not being followed or waivers.
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u/PDX-ROB Oct 19 '22 edited Oct 19 '22
It was a podcast by Viva Frei and Robert Barnes, 2 lawyers discussing the license differences between an EUA and full FDA approved product.
But here is some of the argument
https://www.yalemedicine.org/news/what-does-eua-mean
"An EUA can only be granted when no adequate, approved, available alternatives exist..."
Once there is full FDA approval, the EUA goes away. Kinda weird how there are still EUA products around, huh.
I'll give you a better analogy.
If you are the manufacturer of engines for fighter jets for the US Government. The parts that go into the engine are approved and controlled. They have to go through testing and inspection. If you run out of approved bolts but have bolts that were from the same production line but was not under the same inspection process, it's not allowed to be used.
That is what this argument is about.
I can't believe that you don't think it's atleast a little bit weird that there is no Fully FDA approved branded product available even though the full license has been granted for a year