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- Verdicts for Summit/Akeso, Capricor, Vertex mark FDA’s stacked NovemberAlso lined up are target action dates for Sanofi’s Gaucher disease therapy, GSK’s lung cancer medicine and BridgeBio’s muscular dystrophy drug.
- Regulatory experts urge risk-based, lifecycle validation for AI tools in FDA workAt the RAPS AI in Regulatory Conference in Barcelona, a panel of experts discussed the growing use of AI tools by regulatory professionals. They recommended a risk-based, lifecycle approach to val…