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FDA Puts AI Validation Burden on Drug Sponsors
Original: FDA’s AI Risk-Based Guidance Shifts Validation Burden to Sponsors
The FDA has issued risk-based guidance on artificial intelligence, placing responsibility for validating AI tools squarely on sponsors rather than regulators. Companies developing drugs and clinical trials must now demonstrate their AI systems are reliable and appropriate for their intended use, with scrutiny scaling to the level of risk involved.
Why now: The new FDA guidance directly changes compliance obligations for pharmaceutical and biotech companies using AI.
Evidence
- FDA’s AI Risk-Based Guidance Shifts Validation Burden to Sponsors · The Clinical Trial Vanguard
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