Molecular Dx Exec Named New US FDA Diagnostics Chief
Timothy Stenzel brings experience developing and commercializing new molecular diagnostics, including companion tests, and running a clinical laboratory to his new role as director of US FDA's Office of In Vitro Diagnostics and Radiological Health.
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A Union of Concerned Scientists' survey finds 65% of 354 respondents believe their direct supervisors back them on politically contentious positions; US FDA Commissioner Scott Gottlieb gets glowing reviews.
More than 80 industry, laboratory, health-care provider and patient groups sent a letter to two congressional committees, urging them to advance a bill to modernize the current way FDA regulates diagnostic tests, including possibly a new regulated product category that combines laboratory developed tests and in vitro diagnostics.
Stacking Bricks: FDA Unveils Structure For New Office Of Product Evaluation And Quality, Touts Benefits Of OPEQ
US FDA's Sean Boyd gave an inside look at how the agency plans to organize its Office of Product Evaluation and Quality (OPEQ) – the so-called "super office" that will consolidate a handful of current, distinct offices that handle pre-market, compliance, enforcement and post-market surveillance activities. Plus: Five expected benefits for device-makers (and five for FDA) under the OPEQ reorganization are highlighted.