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New evidence shows that an additional 135 million COVID-19 vaccine doses manufactured at the troubled Emergent BioSolutions’ Bayview, Md., facility will need to be destroyed following the discovery of quality deficiencies. Read More
An FDA inspection of Med Pen Concepts’ facility in Woburn, Mass., found the company lacked documentation of corrective and preventive action (CAPA) procedures, device history records, risk assessments and audit reviews for its plasma pen devices. Read More
Researchers in Europe used Abbott’s i-STAT TBI (traumatic brain injury) test to show how two blood-based biomarkers can effectively predict the initial outcome of such injuries. Read More
Long-term results from the clinical study that supported the FDA’s approval of Channel Medsystems’ Cerene Cryotherapy system show that the device continued its steady reduction of heavy menstrual bleeding after three years. Read More