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US FDA Guidance for Industry: ANDA Submissions – Amendments to ANDAs under GDUFA
FDA revised the final guidance for industry entitled, “ANDA Submissions – Amendments to Abbreviated...
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Ministero Imprese: firmato il decreto per l’attivazione del Fondo IPCEI “Salute 1”
l ministro delle Imprese e del Made in Italy, Adolfo Urso, con apposito decreto, ha disposto l’attivazione...
US FDA Guidance Calls for Three-Step Mitigation Strategy for Nitrosamines
The FDA urges API and drug manufacturers to adopt a three-step mitigation strategy to prevent high levels...
Persone Qualificate delle officine farmaceutiche farmaci VETERINARI - Nuova disciplina Ministero Salute da Settembre 2024
Con riferimento al Regolamento (UE) 2019/6 e D.Lgs. 218/2023, il Ministero Salute ha ritenuto opportuno...
le ultime news
19 Giu
EU’s SPC Manufacturing Waiver - Industry Leaders Outline Difficulties With Mechanism
18 Giu
US FDA Establishes New Regulations for Medical Gases
FDA issues final guidance on facility readiness and GDUFA goal dates
Australia’s TGA sets out transition to newer version of PIC/S Guide to GMP
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