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US FDA’s Bioresearch Monitoring Program Should Evaluate Hiring And Retention Strategies, GAO Says

 
• By Sue Sutter

BIMO inspections and investigators have declined since 2017, and investigators express frustration to the Government Accountability Office that their inspection classification recommendations are downgraded by the Center for Drug Evaluation and Research.

Medical records review
The number of FDA clinical research inspections conducted each year has declined since 2017. • Source: Shutterstock

US Food and Drug Administration bioresearch monitoring investigators prefer conducting on-site inspections over remote regulatory assessments and are frustrated when their inspection classification recommendations are over-ridden by the agency’s drugs center, the Government Accountability Office said in a new report.

Key Takeaways

  • FDA should evaluate the effectiveness of its recruitment and retention efforts for bioresearch monitoring investigators, GAO said.

  • GAO’s review identified a decline in BIMO...

GAO was asked by lawmakers to review the FDA’s program for clinical research inspections. The resulting 53-page report focused on inspections of clinical research conducted for human prescription drugs and...

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