News dal mondo
09
Feb
Pharma expert discusses effort to standardize CMC quality information
The pharmaceutical industry and the US Food and Drug Administration (FDA) are collaborating on a structured...
06
US FDA proposes waiving GDUFA facility fees for domestic manufacturers
The US Food and Drug Administration (FDA) has proposed waiving annual facility fees for the first three...
Computer Software Assurance for Production and Quality Management System Software
FDA is issuing this guidance to provide recommendations on computer software assurance for computers...
04
FDA, EMA officials encourage companies to pilot eCTD 4.0
Companies should increase their efforts to address issues and test their electronic Common Technical...
le ultime news
04 Dic
Farmaci critici: l’Europa punta all’autonomia
AIFA - Procedura semplificata per ulteriori tipologie di variazioni all’AIC di medicinali autorizzati con procedura nazionale o di mutuo riconoscimento/decentrata
02 Dic
FDA Publishes Guidance on Current Good Manufacturing Practice for Medical Gases
Lonza sells Micro-Macinazione site in Switzerland to CDMO Microsize and Schedio Group
01 Dic
Più chimica di base per produzione farmaceutica in Italia
Legge delega per la riforma della normativa farmaceutica: dicembre 2026 come data per il testo definitivo
25 Nov
Contamination Control Reminder: Managing Bacillus Risks in Aseptic Processing
24 Nov
US FDA finds competitive generic therapies launch faster than other generics
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