News from the world

26

Jun

US FDA investigator, experts seek to dispel misperceptions around 483s

Adhering to quality by design (QbD) principles and employing risk-based monitoring strategies should reduce the likelihood of clinical investigators or sponsors receiving a Form 483 following a bioresearch monitoring inspection.

That was the message conveyed by a panel of clinical research experts and a US Food and Drug Administration (FDA) investigator at the DIA annual global meeting on 17 June.  

There are many misperceptions around 483s, but many are “not grounded in reality,” according to David Burrow, director of the Office of Scientific Investigations (OSI) in the Center for Drug Evaluation and Research (CDER)....[RAPS]

26

Jun

FIS di Montecchio Maggiore accelera il percorso di decarbonizzazione industriale

Fabbrica Italiana Sintetici (FIS) di Montecchio Maggiore, tra i principali operatori globali nello...

26

Jun

FIS accelera sulla sostenibilità: biometano e taglio del 63% delle emissioni entro il 2035

FIS, tra i principali operatori mondiali nello sviluppo e nella produzione di principi attivi farmaceutici...

26

Jun

AIFA - Aggiornate le Q&A sui processi autorizzativi AIC

L'Agenzia ha aggiornato il documento Q&A sui processi autorizzativi relativi a procedure nazionali,...

26

Jun

US FDA Issues FY2025 Report on the State of Pharmaceutical Quality

FDA is announcing the fiscal year 2025 Report on the State of Pharmaceutical Quality from the Office...