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...