News dal mondo
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US FDA Proposes Rule to Modernize Drug Manufacturing Registration
Proposed rule would streamline registration for advanced distributed manufacturers and increase visibility into foreign drug supply sources..[US FDA]
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AIFA - Consultazione pubblica per definire i criteri per l’inserimento delle confezioni dei farmaci nell’elenco delle carenze “critiche”
a Legge n. 182/2025 (“Legge Semplificazioni 2025”) ha riformato il sistema sanzionatorio...
21
Ago
EDQM - Update to the guidance for electronic submissions of CEP applications
The European Directorate for the Quality of Medicines & HealthCare (EDQM) has updated the guidance PA/PH/CEP...
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FDA’s GDUFA IV commitment letter supports onshoring of generic drug manufacturing
The agency wants to increase the fee starting in fiscal 2028 for all foreign API, finished dosage form,...
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UE approva acquisto di Recordati da parte di GBL e CVC
La Commissione europea ha approvato, ai sensi del Regolamento UE sulle concentrazioni,...