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.