Risk-Based Approach Means Fewer Trial-Related Inspections

The FDA conducted 949 bioresearch monitoring inspections in fiscal 2011 — 220 fewer inspections than in the previous year — with the decrease spread among all relevant agency centers as they move to a more risk-based approach. The distribution and focus of inspections still looks generally the same as in prior years, despite the 18.8 percent drop in inspections, the agency’s May update to the Bioresearch Monitoring (BIMO) Initiative states.
Devices & Diagnostics Letter