

The FDA is Taking a Big Risk on AI
May 16, 2025
The FDA is rushing to implement generative AI to accelerate drug review processes, sparking heated debate over innovation versus recklessness. Concerns loom about potential pitfalls including AI inaccuracies, known as 'hallucinations,' and the integrity of drug approvals. Panelists discuss the challenges of integrating AI in a tech-limited workforce and question whether safety and standards are being overlooked. Amidst a rapidly evolving landscape, the call for caution echoes, urging a thoughtful approach to AI in healthcare.
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FDA's AI Speed Shift
- The FDA plans rapid AI use to speed scientific reviews from days to minutes.
- This bold move marks a significant shift from the agency's traditionally cautious pace.
AI Models Find New Insights
- Large language AI models analyze vast data to create insights or automate tasks.
- Such models have demonstrated potential to discover novel research insights beyond human capacity.
FDA Loses Digital Native Talent
- Young digital natives are being lost from federal agencies like FDA due to forced retirements.
- Losing this tech-savvy talent threatens the FDA's ability to innovate and govern new technologies effectively.