News from the world
14
Aug
FDA’s GDUFA IV commitment letter supports onshoring of generic drug manufacturing
The agency wants to increase the fee starting in fiscal 2028 for all foreign API, finished dosage form, and contract manufacturing organization facilities....[PharmaManufacturing]
12
Nov
US FDA’s ConOps 2.0 and the Significance of MRA Inspections
Back in June 2017, CDER and the Office of Regulatory Affairs (ORA) signed a “Concept of Operations”...
11
Nov
Farmaci: Italia resta tra Paesi più esposti alla stretta Usa sui prezzi
Anche con i democratici alla guida del Congresso non cambia la linea sul Most favored nation. Per gli...
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...