Bitek
Lifer
- Aug 2, 2001
- 10,676
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The drug is already FDA approved. It's absurdly easier to test a pill for it's contents than it is to actually get a new drug FDA approved. Hell you can buy illegal drugs off the streets and for a hundred dollars or two send it to dancesafe and they will post all of the active ingredients and the amounts present for the world to see. If I can personally get a pill pressed in some guys fucking basement tested at reasonable cost to MYSELF then I gotta assume we, the supposedly greatest nation the earth has ever seen, could easily figure out a method to test foreign drugs for safety. That's just me though, perhaps you have less faith in our abilities.
That's not how it works at all. It's not about just having a QC test for release. The quality system mandated by the FDA (and other agencies) covers the entire chain of the manufacturing process as well as the support functions.
You have to show you have total control of your raw materials to your distribution network, your infrastructure, your personnel, your change and documentation practice, as well as customer complaints and problem tracking. The scope is enormous, but it's what needed to ensure safety, reliability and efficacy.