h-header

news

News dal mondo

08

Ago

Data integrity is ‘biggest issue’ for drug, API firms during inspections, FDA official says

Inspectors at the US Food and Drug Administration (FDA) say lack of data integrity, transparency, record retention, and inadequate controls are some of the most common issues they see during inspections of manufacturers, according to a US Food and Drug Administration (FDA) official who spoke at the Orange County Regulatory Affairs Discussion Group annual conference...[RAPS]

12

Set

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...

11

Set

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...

11

Set

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...

11

Set

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...

slider-banner

h-footer