Clinical Researcher—July 2021 (Volume 35, Issue 5) OVER THE TRANSOM Gary W. Cramer When I read the words of the headline above, I hear them in the ominous voice […]
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 […]
Developing new formulations and therapeutic targets for approved drugs may help treat cancer and other diseases. This is the concept behind the South Dakota State University-led Center for Drug, Disease, […]
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 […]