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Re: Jonjones325 post# 453007

Thursday, 02/29/2024 8:11:32 PM

Thursday, February 29, 2024 8:11:32 PM

Post# of 474269
In the UK a commercial production facility has to be approved before an MAA can be submitted. I'm uncertain of the other regulators, but know in the case of the FDA the inspection of the production facility is part of the NDA or BLA submission and an successful inspection must occur before approval.

Gary
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