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- MDCG: Only manufacturers should assign UDI-DIsThe European Commission's Medical Device Coordination Group (MDCG) says unique device identifiers and device identifiers (UDI-DI) codes used between manufacturers and distributors need to be better…
- FDA issues warning letters for CGMP breaches and inadequate trial consent, EU releases AI transparency guidelinesThe U.S. Food and Drug Administration sent warning letters to several drug manufacturers for not meeting current good manufacturing practice requirements. One firm was also cited for failing to pr…