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- FDA device center outlines FY 2027 guidance plan, targeting AI-enabled devices and change-control plansOn Oct 1, the FDA’s Center for Devices and Radiological Health announced its guidance agenda for fiscal year 2027. The top priority is finalizing guidance for artificial intelligence-enabled medic…
- Key criteria for selecting a biologics CDMO: reliability, cost, technology and partnership fitChoosing the right contract development and manufacturing organization is a strategic move for biotech and biopharma firms, as it can speed development and lower regulatory risk. The top priority…