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Workshop on Devices for Monitoring Warfarin Therapy


Federal Register Notice: FDA will hold a public workshop 3/18 entitled “Point of Care Prothrombin Time/International Normalized Ratio Devices for Monitoring Warfarin Therapy.” Its purpose is to discuss approaches to the analytical and clinical validation of point of care (POC) Prothrombin Time/International Normalized Ratio (PT/INR) in vitro diagnostic devices for improved clinical management of warfarin therapy. Also, the workshop will describe FDA’s process for facilitating the development of safe and effective POC and patient self-testing PT/INR devices. The workshop had been scheduled for 1/25 and was postponed due to unanticipated weather conditions. It will be held from 8 a.m. to 5 p.m. at FDA’s White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, Rm. 1503 (the Great Room), Silver Spring, MD. Contact Rachel Goehe, (240) 402-6565, email: Rachel.Goehe@fda.hhs.gov. To view this notice, click here.