Posts Tagged ‘FDA’
Designing an Audit Trail for AI in Clinical Trials: Aligning with the EU AI Act
As artificial intelligence (AI) continues to transform clinical trials, ensuring transparency, accountability, and compliance has become critical. Central to achieving these goals is the implementation of a robust audit trail system. While the EU Artificial Intelligence Act (EU AI Act) does not explicitly define audit trail requirements for high-risk AI systems, it emphasizes the need…
Read MoreEngaging with the FDA on AI in Clinical Trials: Beyond Traditional Meetings
The U.S. Food and Drug Administration’s (FDA) draft guidance, Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products, offers a comprehensive framework for the integration of artificial intelligence (AI) in drug development. For regulatory professionals, understanding the various engagement options beyond traditional FDA meetings is crucial for effectively…
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