CDC To Yank EUA On Original COVID-19 Test At Year’s End
The US body says it wants to encourage labs to use newer, faster alternatives that can also detect other pathogens.
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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.
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.
A new guidance document from the US regulatory agency reasons that getting early feedback from patient advocates in the trial-design process could improve enrollment, trial completion and data quality.