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Re: XenaLives post# 149412

Friday, 05/04/2018 11:52:02 AM

Friday, May 04, 2018 11:52:02 AM

Post# of 464055

FDA promised five CNS guidances by the end of 2017 and didn't deliver one....



HUH, do we take that as evidence that they got out in front of the process?
An FDA leader once declared she defined the often used regulatory term of .."Establish" to mean..."Define, Document and Do"....So, be generous we would say they have not properly established the processes needed. It is not about blame here it is about people lives.
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