News from the world

15

May

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]

17

Jul

Inside Pharma’s Push for More Resilient Supply Chains

Industry leaders from Samsung Biologics and Fujifilm Biotechnologies discuss how regional manufacturing,...

17

Jul

US FDA CDER plans new guidance on AI, electronic safety report submissions, and more

The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) has...

16

Jul

EU DG SANTE and EMA sign Working Arrangement with New Zealand Ministry of Health

DG SANTE and the European Medicines Agency (EMA) have signed a Working Arrangement with New Zealand Ministry...

15

Jul

Riforma farmaceutica. Via libera della Commissione Sanità del Senato

 Le poche modifiche approvate non cambiano l'impianto della riforma. L’articolo 3 a...