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- Early CDMO engagement: balancing speed with flexibility in CMC planningBringing a new therapy to the clinic requires clinical, non‑clinical, regulatory and CMC activities to move forward together. In early development, having drug material available is often on the cr…
- Japan’s PMDA releases guidance on evaluating generative AI-enabled medical devicesJapan’s Pharmaceuticals and Medical Devices Agency (PMDA) has published a set of review points aimed at medical devices that incorporate generative artificial intelligence. The guidance outlines th…