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- How AI-enabled Software as Medical Devices are Reshaping Regulatory Routes and MedicineAs AI-enabled Software as Medical Devices become more prevalent, regulatory agencies are responding with new guidelines and AI-specific authorisation routes. This article looks at current trends, s…BioSpace · 32m ago↗ source
- EU regulator withdraws Amgen's Tavneos authorization over serious trial breachesEuropean regulators have withdrawn the marketing authorization for Amgen's rare disease drug Tavneos, citing serious breaches in the pivotal clinical trial. The EMA said study staff from ChemoCent…