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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 updated its list of new and revised guidance documents it plans to issue this year to include four new topics since the list was last updated in February....[FDA]
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Inside Pharma’s Push for More Resilient Supply Chains
Industry leaders from Samsung Biologics and Fujifilm Biotechnologies discuss how regional manufacturing,...
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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...
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Riforma farmaceutica. Via libera della Commissione Sanità del Senato
Le poche modifiche approvate non cambiano l'impianto della riforma. L’articolo 3 a...
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China NMPA conducts management review of QMS for regulation of vaccine and drug GMP compliance
The National Medical Products Administration (NMPA) conducted its 2025 annual management review of the...
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