It may surprise you to learn that the Canadian regs are every bit as onerous as the FDA's.
I am somewhat surprised to learn that Puerto Rico, a part of the USA, is beyond the FDA's reach...
I work for a pharm co and you are not being accurate. We do our research in the good ole' USA. And we have a production facility in Puerto Rico that is inspected and regulated by the FDA just as rigorously as any of our other facilities. And it is the only facility we have outside of the US.
We are also inspected and regulated by every other regulatory agency in the world; if we want to sell our meds in Japan, we are inspected and regulated by Japan, the EU, Australia, etc., etc.
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