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Life Sciences
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AI in Drug Discovery: IP, Regulatory Validation, and Licensing Considerations
- September 25, 2026
- Posted by: allan
- Categories: AI & Technology Law, Healthcare Law, Intellectual Property
No CommentsAI is transforming drug discovery, but it raises complex legal questions around patent inventorship, FDA regulatory validation, and licensing agreement structure. This post works through all three systematically for biotech companies, pharma licensors, and their counsel.
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Algorithmic Bias in Clinical Trial Patient Recruitment: FDA Diversity Guidance and AI Tools
- September 23, 2026
- Posted by: allan
- Categories: AI & Technology Law, Healthcare Law
AI patient recruitment tools trained on historically non-diverse datasets can systematically exclude underrepresented populations — directly undermining FDA’s FDORA diversity action plan requirements. This post examines the algorithmic bias risks, the regulatory exposure, and what sponsors must do to stay compliant.
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Can You Audit Your Clinical Trial AI? What FDA Expects
- September 22, 2026
- Posted by: allan
- Categories: AI & Technology Law, Healthcare Law
FDA’s January 2025 draft guidance creates new audit and documentation obligations for every AI tool used in clinical trials. This post examines what inspectors will ask, what vendor contracts must include, and how sponsors can ensure their clinical trial AI is fully audit-ready.
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AI in Drug Development: FDA’s Draft Guidance and What Pharma Companies Must Do Now
- September 20, 2026
- Posted by: allan
- Categories: AI & Technology Law, Healthcare Law
FDA’s January 2025 draft guidance on AI in drug development establishes a seven-step credibility assessment framework that pharma and biotech companies must apply to any AI used to support regulatory submissions. Here is what the context-of-use framework requires and what companies must do now.