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- FDA issues early alert on Edwards Lifesciences transcatheter mitral valve delivery system after balloon burst reportsThe FDA's Center for Devices and Radiological Health issued an early alert about a potential high‑risk issue with certain Edwards Lifesciences delivery systems used in the SAPIEN M3 transcatheter m…
- FDA issues warning letters to manufacturers over CGMP and GLP violationsThe U.S. Food and Drug Administration has sent warning letters to multiple drug manufacturers for failing to meet current good manufacturing practice requirements. The agency highlighted problems e…raps · 6d agoRegulatoryNegative