The transition towards EMA’s new Digital Application Dataset Integration (DADI) user interface
by Giuliana Miglierini The Digital Application Dataset Integration (DADI) network project is aimed to replace the current PDF-based…
IVD regulation in force: new MDCG guidelines and criticalities for innovation in diagnostics
by Giuliana Miglierini The new regulation on in vitro diagnostic medical devices (IVDR, Regulation (EU) 2017/746) entered into…
A new role for EMA and a pilot project for the repurposing of medicines
by Giuliana Miglierini A draft agreement was reached at the end of October between the Council of the…