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CytoSorbents Appoints David D. Cox, PhD, MBA as Vice President - Global Regulatory Affairs
David D. Cox, PhD, MBA, seasoned regulatory professional, tapped to lead CytoSorbents global regulatory initiatives and U.S. FDA approval of CytoSorb MONMOUTH
About this update from Cytosorbents Corporation
[{"type":"text","content":"David D. Cox, PhD, MBA, seasoned regulatory professional, tapped to lead CytoSorbents global regulatory initiatives and U.S. FDA approval of CytoSorb\n\n\nMONMOUTH JUNCTION, N.J., Jan. 21, 2021 /PRNewswire/ -- CytoSorbents Corporation (NASDAQ: CTSO), a critical care immunotherapy leader commercializing its CytoSorb® blood purification technology to treat deadly inflammation in critically ill and cardiac surgery patients around the world, announces the immediate appointment of David D. Cox, Ph.D., M.B.A., as Vice President – Global Regulatory Affairs.\n\n \n \n \n \n \n \n\n \nCytoSorbents taps David D. Cox, former VP Regulatory Affairs at Integra LifeSciences, to lead US FDA CytoSorb approvalDr. Cox was most recently Vice President of Regulatory Affairs for tissue and regenerative technologies at Integra LifeSciences Corporation. He was responsible for successful regulatory approvals of new products and product extensions for the $480 million orthopedics and tissue technologies division. Dr. Cox led efforts to develop U.S. FDA Premarket Approvals (PMA), 510(k)s, and Investigational New Drugs (IND), as well as international registrations under the European Union (E.U.) Medical Device Directive (MDD) and the new Medical Device Regulation (MDR). In addition, he effectively integrated the product lines of the Derma Sciences and BioDlogics acquisitions, expanding his regulatory responsibilities to include advanced wound care and human tissue products.\nPrior to Integra LifeSciences, Dr. Cox held regulatory positions at several medical device companies, including Terumo BCT, where he was responsible for Class II and Class III submissions in the Center for Devices and Radiologic Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) branches of the FDA related to pathogen reduction and blood processing technologies. Earlier experiences include authoring numerous regulatory submissions for the U.S., E.U., Canada, and Japan for Medtronic's Cardiac Surgery division.\nDr. Cox received Regulatory Affairs Certification (RAC) for the U.S., Europe, and Canada. He received his Ph.D. in Bio-inorganic Chemistry from the University of Minnesota, his M.B.A. from Carnegie Mellon University, and his B.A. in Chemistry from Bethel College where he graduated magna cum laude.\nDr. Cox stated, \"I am excited to join the CytoSorbents tea...