News dal mondo
17
Lug
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]
17
Lug
Inside Pharma’s Push for More Resilient Supply Chains
Industry leaders from Samsung Biologics and Fujifilm Biotechnologies discuss how regional manufacturing,...
16
Lug
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
Lug
Riforma farmaceutica. Via libera della Commissione Sanità del Senato
Le poche modifiche approvate non cambiano l'impianto della riforma. L’articolo 3 a...
14
Lug
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...
le ultime news
07 Mag
AIFA - Sistema informatico Workflow Officine Materie Prime - aggiornamento
30 Apr
AIFA pubblica il Terzo Position Paper sui farmaci biosimilari
29 Apr
US GDUFA IV Talks Reach Tentative Agreement; America First Application Fee Waiver Added
28 Apr
Sun Pharma compra Organon
27 Apr
US QMM: Participants scored well on commitment to quality, lower on advanced manufacturing
23 Apr
Top Drugs at Risk of Supply Shortages
23 Apr
Regulatory considerations for pharmaceutical excipient selection
21 Apr
TGA clarifies therapeutic goods are unaffected by chemical production and import ban