Latest From Bowman Cox
FlexBiosys wins award; others to follow. New capacity may also benefit manufacture of monoclonal antibodies and cell and gene therapies.
US FDA is looking at risk-based approach for reporting changes in out-of-stock components such as plastic bioreactor bags, filters and tubing sets that are in short supply.
Summary judgment puts 20-year-old effort to define ‘inordinate’ out-of-state drug compounding back on slow track.
Quality and the measure of a firm: Toyobo’s particulates and resins, Galenicko’s sanitation, Breckenridge’s product chemistry and Fujifilm’s cross-contamination risk.
High-level board will bring together information from across FDA drug center and work to increase supply chain transparency, says CDER’s Jacqueline Corrigan-Curay.
XGBoost model sees site complexity contributes to quality risk, but misses device-related issues, says third FDA pharmaceutical quality report.