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Re: mrplmer post# 455270

Thursday, 03/28/2024 5:32:39 PM

Thursday, March 28, 2024 5:32:39 PM

Post# of 459845
Is there a reluctance to discuss informal guidance from the FDA, as opposed to formal guidance from the EMA? Serious question, not rhetorical. It seems to me that the EMA process is different in that you can’t submit an application without permission to do so? Is the FDA’s “behind the scenes” opinion considered to be taboo for public discussion by a company?
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