FDA’s Clinical Inspections Declined Amid Staffing Challenges

Inspections conducted by the FDA to ensure the quality and integrity of clinical research for drug approvals have decreased in recent years, the US Government Accountability Office said in a report Monday.

The federal watchdog’s report found clinical research inspections by the Food and Drug Administration have faced challenges in recruiting and retaining investigators in its Bioresearch Monitoring (BIMO) program, which have resulted in fewer inspections and a less experienced workforce.

The accountability office was asked to review the FDA’s BIMO program as it relates to ensuring drugs approved for marketing in the US are safe and effective.

Among the ...