News from the world
31
Jul
FDA unveils FY 2027 user fee rates
The US Food and Drug Administration (FDA) has published its user fee rates for FY 2027 across its prescription drug, generic drug, biosimilar, medical device, and over-the-counter drug programs. The rates are calculated by factoring in the agency’s resources against the number of applications it expects to receive over the next fiscal cycle based on historical trends...[US FDA - Federal Register]
29
Jul
Esenzione sui dazi per taluni prodotti provenienti dagli USA
Il 25 giugno 2026 è stato pubblicato il REGOLAMENTO (UE) 2026/1455 DEL PARLAMENTO EUROPEO E DEL...
17
Jul
Inside Pharma’s Push for More Resilient Supply Chains
Industry leaders from Samsung Biologics and Fujifilm Biotechnologies discuss how regional manufacturing,...
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...
16
Jul
EU DG SANTE and EMA sign Working Arrangement with New Zealand Ministry of Health
DG SANTE and the European Medicines Agency (EMA) have signed a Working Arrangement with New Zealand Ministry...
latest news
31 Jul
FDA unveils FY 2027 user fee rates
29 Jul
Esenzione sui dazi per taluni prodotti provenienti dagli USA
17 Jul
Inside Pharma’s Push for More Resilient Supply Chains
17 Jul
US FDA CDER plans new guidance on AI, electronic safety report submissions, and more
16 Jul
EU DG SANTE and EMA sign Working Arrangement with New Zealand Ministry of Health
15 Jul
Riforma farmaceutica. Via libera della Commissione Sanità del Senato
14 Jul
China NMPA conducts management review of QMS for regulation of vaccine and drug GMP compliance
14 Jul
AIFA: “Cerca un farmaco”: disponibili nuove informazioni sullo stato di commercializzazione dei medicinali