People do not have a right to their own facts, jus
Post# of 72447
(Total Views: 302)
Posted On: 03/21/2019 7:12:51 PM
People do not have a right to their own facts, just to their own opinions.
A two-second Google search revealed this article comparing the 2 approval processes. Indeed Europe historically is perceived to approve drugs more quickly, and they have approved drugs that the FDA has not.
It would be nice if people would spend two seconds researching before calling into question what other people have already researched and know.
https://www.sciencedirect.com/science/article...2X16300638
There is, however, lots of confusion because of the varied approval processes in the EU. Some of the drugs that were approved quickly in the EU but are not approved here were approved years ago. So as to the situation now, especially with Brexit -- well, there will be some question about that.
The question of how fast a drug can be approved also depends on whether it's approved in one country and then submitted for approval in the rest of the EU. Do you count as "approved" when the one country approves it, or when the whole EU approves it? I'd vote for the former.
My take after reading the whole article is that there is absolutely no justification for the claim that it's more difficult to get approval from the EU than from the FDA.
A two-second Google search revealed this article comparing the 2 approval processes. Indeed Europe historically is perceived to approve drugs more quickly, and they have approved drugs that the FDA has not.
It would be nice if people would spend two seconds researching before calling into question what other people have already researched and know.
https://www.sciencedirect.com/science/article...2X16300638
Quote:
A frequently held assertion is that slower FDA approval processes deprive American citizens of effective DADs that are available to Europeans (2), and critics have characterized FDA processes as “slow, risk averse, and expensive” (3). However, the Institute of Medicine determined that current FDA pre-marketing procedures for medical devices are insufficient to assure device safety, particularly those approved largely on their similarity to previously cleared “predicate” devices, rather than on prospective, randomized clinical trials (4). In the EU, concerns abound that DADs may be approved too quickly, to the detriment of patient safety. In recent years, there have been calls to tighten approval processes and to establish regulatory consistency between the FDA and the EU. Efforts include recent legislation in the U.S. Congress to facilitate release in the United States of drugs that have already achieved European approval (5).
There is, however, lots of confusion because of the varied approval processes in the EU. Some of the drugs that were approved quickly in the EU but are not approved here were approved years ago. So as to the situation now, especially with Brexit -- well, there will be some question about that.
The question of how fast a drug can be approved also depends on whether it's approved in one country and then submitted for approval in the rest of the EU. Do you count as "approved" when the one country approves it, or when the whole EU approves it? I'd vote for the former.
My take after reading the whole article is that there is absolutely no justification for the claim that it's more difficult to get approval from the EU than from the FDA.
(1)
(0)