Generic User Fee Agreement Includes FDA Pledge To Determine Best Use Of Foreign Regulator Inspections
This article was originally published in The Pink Sheet Daily
Draft commitment letter could be first step down globalization road in which FDA relies more on foreign governments to boost manufacturing oversight.
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Leveraging foreign surveillance inspections could help FDA ensure more sites are inspected more often.
Both sides may agree to overlook “areas of divergence” if they don’t appear significant.
FDA notes that it may not be evident right away whether an inspection will be required as part of the review.