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- FDA leadership shift raises questions for labs
A leadership change at the Food and Drug Administration (FDA) is drawing close attention across the health care sector.
The latest: FDA Commissioner Marty Makary, MD, resigned on May 12 after a 13-month tenure marked by internal tension and policy disputes.
The impact: FDA decisions shape oversight of diagnostics, emerging technologies, and review pathways that affect how labs bring tests to patients.
The backstory: His tenure drew criticism from multiple groups over vaccine policy, drug approvals, and regulatory decisions that some viewed as inconsistent.
The CAP view: Stability and transparency at the FDA are key to ensuring predictable regulatory pathways that support patient care and innovation.
What’s next: Deputy Commissioner for Food Kyle Diamantas will serve as acting commissioner while a permanent replacement is considered.