FDA Switching to Real-Time Audits as Part of Its BIMO Initiative

Reversing its recent practice, the FDA is once again conducting real-time inspections of clinical trials, rather than waiting until after it receives an approval application for a drug or device. When the Bioresearch Monitoring (BIMO) program began in 1976, most inspections were real-time, according to the FDA Division of Scientific Investigations. “Over time, inspections began to be application-focused,” Leslie Ball, director of scientific investigations for CDER, said. Now the agency has decided to switch focus once again, making real-time inspections a part of its quality systems approach to clinical trial evaluation.
Clinical Trials Advisor