News dal mondo

15

Mag

US FDA official details top observations from QMSR inspections

The top observations identified in Form 483 reports from inspections conducted under the recently implemented Quality Management System Regulation (QMSR) include risk management, outsourcing and purchasing, and complaint handling and feedback....[RAPS]

15

Mag

US FDA’s New AI-Informed Inspection Pilot and What It Means for Industry

We have written on this blog about FDA’s modernization agenda from several angles lately—from...

15

Mag

EU Regulators discuss new pharma legislation, AI, and more

A panel of European regulators answered questions during a town panel discussion at RAPS Euro Convergence...

15

Mag

European Commission outlines plans to mobilize EMA to diversify supply chains

he European Commission has adopted a Global Health Resilience Initiative that gives EMA a role in diversifying...

13

Mag

Deal on tackling EU shortages of essential medicines

Prioritise investment in EU manufacturing capacity to increase autonomy “Buy European”...