Regardless of the source, anomalies need to be captured by and documented in a company’s quality management system followed by an evaluation of the risk of the anomaly, Peter said. Once an ...

Companies that invest in quality management initiatives can incur lower costs related to defects, waste, and recalls compared to those that do not make such investments, according to a white paper ...

The U.S. Food and Drug Administration (FDA) announced a new process called “Rare Disease Evidence Principles” (RDEP), under which eligible drugs and biologics for ultra-rare diseases caused by known ...