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Posted On: 08/07/2020 11:50:11 PM
Post# of 148903
It’s the FDAs job to specifically direct NP and his crew.
Here’s an example with just manufacturing. They can easily say no more Samsung.
“Pharmaceutical Quality/Manufacturing Standards (CGMP) [Current Good Manufacturing Practice (CGMP)]
21 CFR Part 314 and Part 600. Application and licensing submission requirements for new and generic drug applicants.
21 CFR Part 210. Current Good Manufacturing Practice in Manufacturing Processing, packing, or Holding of Drugs.
21 CFR Part 211. Current Good Manufacturing Practice for Finished Pharmaceuticals”
I’m not posting each section here’s the link.
https://www.fda.gov/drugs/pharmaceutical-qual...egulations
There are entire laws about this subject, the FDA can use as leverage to do things, like have them manufacture in the U.S.
That’s their job to ‘steer’ them in the right direction, so no it would be illegal if they weren’t doing that. If they aren’t then watch and wait. Heads will roll at the FDA at some point if they haven’t already and we don’t know about it.
I’m assuming the FDA is under a lot of pressure to get this right. They are playing god at this point. We will have to see how this plays out. Regardless they have a lot of say how NP does business.
So to your second point again. I think that’s very inaccurate to say that the FDA, “And thinking the FDA has steered anyone in any direction is ludicrous”. That’s a huge part of their job...
Here’s an example with just manufacturing. They can easily say no more Samsung.
“Pharmaceutical Quality/Manufacturing Standards (CGMP) [Current Good Manufacturing Practice (CGMP)]
21 CFR Part 314 and Part 600. Application and licensing submission requirements for new and generic drug applicants.
21 CFR Part 210. Current Good Manufacturing Practice in Manufacturing Processing, packing, or Holding of Drugs.
21 CFR Part 211. Current Good Manufacturing Practice for Finished Pharmaceuticals”
I’m not posting each section here’s the link.
https://www.fda.gov/drugs/pharmaceutical-qual...egulations
There are entire laws about this subject, the FDA can use as leverage to do things, like have them manufacture in the U.S.
That’s their job to ‘steer’ them in the right direction, so no it would be illegal if they weren’t doing that. If they aren’t then watch and wait. Heads will roll at the FDA at some point if they haven’t already and we don’t know about it.
I’m assuming the FDA is under a lot of pressure to get this right. They are playing god at this point. We will have to see how this plays out. Regardless they have a lot of say how NP does business.
So to your second point again. I think that’s very inaccurate to say that the FDA, “And thinking the FDA has steered anyone in any direction is ludicrous”. That’s a huge part of their job...
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