3 ms·
I am pretty sure regulators in Europe do not use the same drug approval process that was used in the 1960s. For example: >...The Mutual Recognition Agreement
by opo 8y ago
I am pretty sure regulators in Europe do not use the same drug approval process that was used in the 1960s. For example:
>...The Mutual Recognition Agreement (MRA) between FDA and European Union allows drug inspectors to rely upon information from drug inspections conducted within each other’s borders.
https://www.fda.gov/internationalprograms/agreements/ucm598735.htm https://www.fda.gov/internationalprograms/agreements/ucm5987...
Approving new drugs without adequate testing will cost lives, being over cautious can also cost lives though. An example of that was the FDA refusing to allow beta-blockers:
>...For example, consider FDA’s incredibly long delay in
approving beta-blockers to reduce the risk of second heart
attacks. By the mid-1970s this had been documented in clinical
trials, and a number of beta-blockers were approved for this
use in Europe. But in the U.S., FDA imposed a moratorium on
beta-blocker approvals due to the drugs’ carcinogenicity in
animals. ... Finally, in 1981 FDA approved the first such drug, boasting
that it might save up to 17,000 lives per year. That meant, of
course, that as many as 100,000 people may have died waiting
for FDA to act —an explosive point, but one that very few
journalists pursued
http://www.jpands.org/vol15no4/kazman.pdf http://www.jpands.org/vol15no4/kazman.pdf