FDA Conducting Fewer Bioresearch Inspections Under Risk-Based Approach

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. When determining which trials to inspect, all centers are increasingly relying on risk-based approaches. CDRH, like CBER, uses an early intervention program, in which ongoing studies are identified for inspection using risk-based criteria.
The GMP Letter