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Wolfy3

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Wolfy3

Re: purplehp post# 84377

Saturday, 06/16/2018 7:17:25 AM

Saturday, June 16, 2018 7:17:25 AM

Post# of 144812
I don’t have a lot of experience in IND filing but have an understanding of FDA requirements from years of working on the production side - when we changed to serum free media we had to requalify our process which included 5 full scale production runs a lot of testing and re file for approval with FDA EMA etc and had to get that approval before marketing the product- you basically can’t change anything without agency review and approval. hope that helps?
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