Have a read, companies change their manufacturing processes alot more than you think. If new trials had to be run every time it would be prohibitively expensive and generic drugs would not be financially feasible.
"I have seen SI state the exact opposite in a recent video interview."
Please share the link to this quote I have never heard SI state that a new trial will be required for 3d manufacturing.
https://www.fda.gov/media/109615/download
MSB Trading 2021 - paradigm shift, page-6073
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