Drug Regulator's New Rules for Expert Panel Include Stricter Attendance Policy

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Posted by AI on 2025-07-18 14:05:00 | Last Updated by AI on 2025-07-18 11:27:10

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Amid growing calls for drug approval reform, the FDA is tightening rules for its expert panels, with a focus on attendance and accountability.

The U.S. Food and Drug Administration (FDA) is shaking up how its expert panels operate, stating in a recently published document that panelists who regularly miss meetings may face removal, marking a new level of performance accountability.

The move comes after the FDA has faced increasing scrutiny over its drug approval process and recommendations from its expert panels.

The agency wrote that it is "important that the FDA have the ability to rely on the participation of its advisory committee members and that patients, providers, and manufacturers have confidence in the advisory process and the transparency it brings to FDA decision-making."

The FDA regularly convenes expert panels to provide advice and recommendations on a wide range of topics, including drug approvals, safety issues, and the effectiveness of medical treatments.

These committees are crucial in providing independent expertise to inform the FDA's decision-making process.

Typically, these committee members serve on a volunteer basis and are experts in their respective fields, including doctors, researchers, and academics.

While the panels' advice is not binding, the FDA usually follows their recommendations.

The agency's decision to strengthen the rules around attendance and participation reflects a broader effort to ensure that its expert panels are operating effectively and efficiently.

It remains to be seen how these new rules will impact the FDA's decision-making process and the overall drug approval process.

Despite calls for increased accountability, some argue that the potential for bias and groupthink among frequently participating experts should be addressed.

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