An effective corrective and preventive action (CAPA) plan for clinical trial practitioners focuses like a laser on a protocol deviation’s root cause by relentlessly asking “why did something happen,” says […]
If we as an industry learn anything from battling the COVID-19 pandemic, David Burrow, PharmD, JD, director of the Office of Scientific Investigations, Office of Compliance, Center for Drug Evaluation […]
Regulators for the U.S. Food and Drug Administration (FDA) “like to see a focus on corrective and preventive actions” (CAPAs) after they issue a Form 483 to managers of a […]
U.S. Representatives Bobby L. Rush (D-Ill.) and Brian Fitzpatrick (R-Pa.) have introduced the Long-term Opportunities for Advancing New Studies (LOANS) for Biomedical Research Act (H.R. 3437), new bipartisan legislation that […]
A five-year community outreach and engagement effort by the Abramson Cancer Center at the University of Pennsylvania (Penn) in Philadelphia to increase enrollment of Black patients into cancer clinical trials […]