News dal mondo

18

Set

US FDA Launches Pilot To Expedite INDs

FDA has launched a pilot program to expedite review of investigational new drug (IND) filings with applications for the pilot due by October 30. It is part of the agency’s Operation TrialBlazer initiative, designed to make the US more competitive in early-stage research....[DCAT]

04

Nov

US FDA unannounced foreign inspections in China and India increased in FY 2026

 A top US Food and Drug Administration (FDA) enforcement official announced that the agency conducted...

30

Ott

US FDA Releases Updated Concept of Operations for the Facility Evaluation and Inspection Program for Human Drugs

FDA has published the revised Integration of the FDA Facility Evaluation and Inspection Program for Human...

30

Ott

Importazione di sostanze attive - Elenco dei Paesi terzi riconosciute equivalenti EU

DECISIONE DI ESECUZIONE (UE) 2026/2347 DELLA COMMISSIONE del 23 ottobre 2026 che modifica la decisione...

30

Ott

Accesso ai Servizi Online AIFA: evoluzione digitale all’insegna della sicurezza e della semplificazione

L’Agenzia Italiana del Farmaco prosegue il percorso di efficientamento e digitalizzazione delle...