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FDA Raises the Bar: What Increased Scrutiny of Foreign Clinical Trials Means for You

Wed, Oct 07

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Biltmore Innovation Center

The FDA has signaled more inspections and closer review of clinical trial data generated outside the US, with China drawing particular attention. This session explains what the agency is signaling.

FDA Raises the Bar: What Increased Scrutiny of Foreign Clinical Trials Means for You
FDA Raises the Bar: What Increased Scrutiny of Foreign Clinical Trials Means for You

Time & Location

Oct 07, 2026, 2:00 PM – 3:30 PM

Biltmore Innovation Center, 855 W. Peachtree St. NW, Atlanta, GA 30308

About the event

The FDA has signaled more inspections and closer review of clinical trial data generated outside the US, with China drawing particular attention. This session explains what the agency is signaling.

Key takeaways:

  • What the FDA has signaled. Understand the agency's plans for more foreign inspections, updated site selection criteria, and earlier discussions with sponsors about where their data comes from.

  • Where the policy debate is heading. Learn about congressional proposals that could restrict or condition the use of China-sourced trial data, and what they would mean for pending programs.


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