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
24 Nov
AI Act, la Commissione UE propone rinvio fino a 16 mesi per le norme sui sistemi ad alto rischio
20 Nov
US vulnerable to China's API dominance
Medicinali critici: Parlamento UE verso l’adozione del Regolamento
17 Nov
Transizione 4.0 e 5.0, bonus innovazione : come cambia la mappa degli incentivi alle imprese
AIFA - Applicazione della nuova “Classification Guideline” relativa alle Variazioni AIC dal 15 gennaio 2026
11 Nov
EDQM clarifies the stepwise process to getting a CEP or having a change approved
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