FDA weighs changes to clinical trial design, drug development and use of AI in trials
An FDA overview dated 15 September 2026 says the agency is considering changes to trial design, drug development and the use of AI in clinical trials.
Who is affected and how
- pharmaceuticals
- Changes to trial-design and AI-use rules may affect development plans, so they are worth tracking.
- health policy
- Rules on the use of AI in clinical trials could serve as a guide.
Sources
- FDA Contemplates Changes in Trial Design, Drug Development, and Use of AI in Clinical Trials | Leaders in Pharmaceutical Business Intelligence Group, LLC, Doing Business As LPBI Group, Newton, MApharmaceuticalintelligence.com · Sep 15, 2026
- AI Transforming Clinical Trial Design and Executionpharmaadvancement.com · Sep 15, 2026
- Agentic AI in Pharma: Clinical Trials, Compliance & Drug R&Dchimeratechnologies.com · Sep 15, 2026
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