FDA Updates COVID-19 Test Policy; Shifts Focus From EUAs
As part of a policy revamp, FDA encourages COVID-19 test developers to pursue traditional premarket review pathways rather than emergency use authorizations.
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OIG: FDA’s EUA Approach Allowed Bad Tests To Reach Market
A review by a government watchdog found the FDA’s review process for COVID-19 diagnostics was plagued by issues including allowing low-quality tests to slip through, high reviewer workloads, and manufacturer frustration.
First EUA In US For OTC Test To Detect COVID-19, Flu, RSV Granted To Labcorp
Agency issued an emergency use authorization to Labcorp for its OTC that detects COVID-19, flu and respiratory syncytial virus.
News We’re Watching: Medtronic To Buy EOFLow, Neuralink Cleared For Human Trials, NICE Backs Genetic Tests
This week, Medtronic said it would pay $738m for insulin patch firm EOFlow; Neuralink got an FDA OK for first-in-human trials; and UK agency NICE backed genetic tests for stroke patients and digital therapeutics for mental health conditions.