Under New Leadership, FDA Diagnostics Office To Tighten Its Control
This article was originally published in The Gray Sheet
Executive Summary
Taking its cue from the new, more aggressive FDA administration, the agency's diagnostics office aims to tighten its regulatory control over commercial tests and, potentially, lab-developed assays, according to the new director of the Office of In Vitro Diagnostic Device Evaluation and Safety, Alberto Gutierrez
You may also be interested in...
Dx Departure: US FDA's Diagnostics Chief Gutierrez Steps Down
Alberto Gutierrez left FDA and government this week in a planned retirement. He was director of the office that oversees pre- and post-market programs for in vitro diagnostics and radiology devices, an office where several holes already exist in top management slots.
Guaranteeing Quality Of Lab-Developed Molecular Tests Is Difficult - AHRQ
A new report on laboratory-developed molecular tests lends another voice to arguments favoring enhanced oversight of these non-FDA-regulated products and services
Guaranteeing Quality Of Lab-Developed Molecular Tests Is Difficult - AHRQ
Draft report points to New York state's clinical laboratory evaluation program as a model for overseeing the controversial tests.