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]