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]
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...
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...
10
Aug
EMA issues updated guidance on shortage prevention plans ahead of legal deadline
The European Medicines Agency (EMA) has issued an updated guideline to assist marketing authorisation...
latest news
21 Aug
EDQM - Update to the guidance for electronic submissions of CEP applications
14 Aug
FDA’s GDUFA IV commitment letter supports onshoring of generic drug manufacturing
11 Aug
UE approva acquisto di Recordati da parte di GBL e CVC
10 Aug
Wise Equity investe in E-Pharma Trento
10 Aug
EMA issues updated guidance on shortage prevention plans ahead of legal deadline
03 Aug
Destiniamo parte dei fondi per la difesa alla produzione di farmaci fuori brevetto
31 Jul
FDA unveils FY 2027 user fee rates
29 Jul
Esenzione sui dazi per taluni prodotti provenienti dagli USA