Why would a Canadian Vaccine trial require an FDA approval ?
Is not the FDA a US regulatory body and not Canadian
- FrozenPondLv 79 years agoFavorite Answer
It needs FDA approval because,apparently,the clinical trials(tests on people) will be done in the USA.
While the research was done in Ontario,note that the project was funded by a Korean drug company-(Sumagen-through a Canadian subsidiary)-how and why they test in the US could be any number of things-it's possible they don't have the staff in Canada(according to their website they have all of 6 people working in London at UWO)-this (testing)would likely involve teams of doctors and it's possible they already have that structure in place in the USA.
from the website:
The office in London with a staff of six, are managing the project to manufacture the materials for clinical trials, conduct non-clinical studies, and coordinate through a consultant to meet the requirements of the FDA in the United States to obtain approval to conduct human clinical trials.
- Michael TLv 79 years ago
if you are talking about the recent development of ab vaccine for HIV infected individuals to prevent full blown aids
there is no funding available in Canada right now Private or Government to cover the cost of a drug trial for this product
regardless of that FDA approval would be required before use in the states and that would involve separate trials down there anyway
the FDA does not recognize most studies done in Canada and we do not recognize most FDA studies
- USAFisnumber1Lv 79 years ago
No it would not.
However, if they do a drug trial in Canada and it does not meet the standards required of the FDA, when the trial is over they can not use the results of that trial to get the drug approved in the USA.
For example, the FDA requires a drug trial to be done on men AND WOMEN. If the company did the trial in Canada only on men, the FDA would not accept the results.
To avoid that, most companies that want to eventually market a drug in the USA will go to the FDA with their proposed drug trial to get the FDA to sign off on it that the results of that trial, if done as stated in the proposal, will be accepted by the FDA.
- smoakLv 44 years ago
an prolonged time area II is basically the start of a sparkling drug being examined there are various greater until now the FDA approves any drug for human beings to apply i might say basically for II until ultimately the docs get the outcomes they're searching for or the outcomes they don't want to hearken to then they'll would desire to pass on..
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- Weise EnteLv 79 years ago
Where is the trial being held?
Canada, or the US?
That is the vital piece of information not included in the article. Realistically, HIV rates are higher in the US, so that's where they are probably doing the study.