News from the world
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...
latest news
28 Jan
FDA official offers tips on leveraging AI in drug manufacturing
Testo unico legislazione farmaceutica. La delega torna a Palazzo Chigi
27 Jan
Tariff Uncertainty Drives Short-Term Manufacturing Surge as Global Pharmaceuticals Enter Fragmented Growth Phase
23 Jan
Produzione di API: processi, rischi e scenari futuri
21 Jan
Farmaci. L’Europa cambia le regole: per la sicurezza sanitaria arriva il “Compra europeo”
Farmaci: OK Parlamento europeo a posizione su Medicinali Critici
Farmaci essenziali, via libera del Parlamento UE al Critical Medicines Act
12 Jan
AIFA - Direzione Uffici a strutture complesse dal 1 gennaio 2026
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