CDC To Yank EUA On Original COVID-19 Test At Year’s End
Executive Summary
The US body says it wants to encourage labs to use newer, faster alternatives that can also detect other pathogens.
You may also be interested in...
‘Never Again’: Shuren Talks COVID-19 Lessons At FDA Small Business Event
Despite insisting that he would never want to relive the stressful days of 2020, US FDA device center chief Jeff Shuren said the pandemic nevertheless led to improvements in regulatory flexibility and communication with industry.
FDA Responds To Coronavirus By Getting Out First Emergency-Use Novel Coronavirus Diagnostic
The US agency on 4 February issued its first Emergency Use Authorization of a 2019-novel coronavirus test by enabling emergency use of the Centers for Disease Control and Prevention’s 2019-nCoV Real-Time RT-PCR Diagnostic Panel. The move will allow use of the test at any CDC-qualified lab across the US.
Report Finds Digital Diabetes Tools Deliver No ‘Meaningful Clinical Benefits'
A new report from health economics group the Peterson Health Technology Institute found that apps to help patients manage their blood sugar levels delivered few of the promised benefits. However, a digital therapeutics industry association says PHTI’s research cast too narrow a net.