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Posted On: 10/27/2020 7:25:39 AM
Post# of 148903
I took it to mean that they would accept/deny application within 2 weeks, which is crazy fast compared to our FDA. I believe our FDA takes 60 days. Perhaps the US could take a page from their book unless the longer time frame is because we have so many more drugs to look at. I gotta believe the process to look at the data and manufacture info will take a few months after that.
Hopefully they have an equivalent pdufa date so that we can get an idea of how long the wait is.
Hopefully they have an equivalent pdufa date so that we can get an idea of how long the wait is.
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