Are there likely to be any stats or history relating to other products/companies that have had the FDA factory inspection and had the product fail to receive approval for any other reason than the factory be non compliant?
This would be very interesting may shed some light on how serious or close the FDA is to approval.
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- Ann: FDA Schedules GvHD Pre-License Manufacturing Inspection
Ann: FDA Schedules GvHD Pre-License Manufacturing Inspection, page-20
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