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AI and Adverse Events: Tech Not Ready For Prime Time For Case Safety Reports, US FDA Says

 
• By Sarah Karlin-Smith

FDA leadership weighs in on limitations of AI as part of rollout of new technology meeting program that looks to give industry and other stakeholders a chance to inform future regulation.

Robot and adult man staring each other down
AI not yet ready to replace humans for case safety reports, FDA's Robert Ball said • Source: Shutterstock

Artificial intelligence is not yet able to fully replace human experts in important drug safety work, FDA cautions.

Key Takeaways

  • Causality assessments for adverse events still require human expertise and judgement, US FDA officials say. Pharma should keep this in mind as it explores using AI for case safety reports. 

  • New emerging drug safety technology meetings will inform future FDA regulatory advice and policies on how AI and other emerging technologies should be used for pharmacovigilance. But they are not intended for companies to seek regulatory advice on compliance with regulations

The pharmaceutical industry is exploring the application of AI to the processing of individual case safety reports (ICSR), Center for Drug Evaluation and Research Deputy Director in the Office of Surveillance and Epidemiology Robert Ball said in a

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