Because then you can’t sue someone as easily in the US when you find out the drug popular in Europe actually caused cancer 50 years later.
The US has to be sure it’s completely safe. Or that it will make enough money to outweigh the lawsuits later…
The US has to be sure it’s completely safe. Or that it will make enough money to outweigh the lawsuits later…
That doesn't make sense to me, who does US refer to in this case?
The manufacturer is the one that would be sued and they generally only want to expediate process.
FDA is one that aproves/denies application. They wouldn't get sued for using data from other countries (or at least no more that they already are).
Of the four countries that aren't the US, I'm sure that all have regulatory safety standards that would satisfy the safety and efficacy expectations of the American public.