News from the world

17

Jul

US FDA CDER plans new guidance on AI, electronic safety report submissions, and more

The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) has updated its list of new and revised guidance documents it plans to issue this year to include four new topics since the list was last updated in February....[FDA]

21

Aug

EDQM - Update to the guidance for electronic submissions of CEP applications

The European Directorate for the Quality of Medicines & HealthCare (EDQM) has updated the guidance PA/PH/CEP...

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,...

11

Aug

UE approva acquisto di Recordati da parte di GBL e CVC

La Commissione europea ha approvato, ai sensi del Regolamento UE sulle concentrazioni,...

10

Aug

Wise Equity investe in E-Pharma Trento

Wise Equity, società di gestione del fondo Wisequity VI, e Unifarm, azionista unico...