3 ms·
Alex, I have lived in more than one country, so I have made specific observations of precisely how little influence the FDA has on the drug regulations of other
by cstross 14y ago
Alex, I have lived in more than one country, so I have made specific observations of precisely how little influence the FDA has on the drug regulations of other countries.
That's beside the point.
The same trials that are used as the basis for product license applications to the FDA are used for license applications to the UK's MHRA.
The process of generating an approval and granting a product license is different, but the same data feeds into the process, giving rise to similar outcomes.
(Also: please do not confuse controlled substances with prescription-only medicines. Two different sets of law apply, one superimposed on top of the other, just to add to the confusion.)
At risk of resorting to an appeal from authority, I speak as a retired pharmacist: the process of obtaining product licenses for pharmaceuticals isn't so much broken as it's irrelevant, because as long as the submission relies on data that can be massaged by the applicant (who stands to profit from it), the outcome will reflect the inputs. (In other words: garbage studies go in, questionable product licenses come out.)