News from the world

18

Sep

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]

06

Nov

Il Pharma package europeo cambia gli equilibri tra innovatori e genericisti

Il Pharma package europeo rappresenta la prima revisione dal 2004 della legislazione farmaceutica continentale....

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

Oct

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

Oct

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...