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Foreign plant post-approval inspections expected to account for 60% of drug inspections.

This article was originally published in The Tan Sheet

Executive Summary

FOREIGN PLANT POST-APPROVAL SURVEILLANCE EXPECTED TO INCREASE to 60% of annual international inspections, FDA's Center for Drug Evaluation & Research states in the agency's "Summary Report of the Foreign Inspection Working Group." CDER expects to shift the focus of its overseas inspections from pre-approval examination to a "risk-based" strategy that is anticipated to triple the percentage of postapproval surveillance inspections.
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