FDA CMC Pilot Program: More NDA Data, Less Inspectional Oversight
This article was originally published in The Pink Sheet Daily
Executive Summary
FDA is seeking 12 original NDAs ready for submission by the end of 2006 for a pilot program that will reshape the kind of information included in the chemistry, manufacturing and controls section of applications. Manufacturing would be governed more by “process understanding” and less by standard operating procedures, FDA says.
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