News dal mondo

26

Giu

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]

11

Ago

UE approva acquisto di Recordati da parte di GBL e CVC

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

10

Ago

Wise Equity investe in E-Pharma Trento

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

10

Ago

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...

03

Ago

Destiniamo parte dei fondi per la difesa alla produzione di farmaci fuori brevetto

Le “montagne russe” provocate dalla violenta ma ondivaga politica sui dazi di Trump e sui...