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FDA Addresses 'Misinformation' Concerning Delayed Approval Of Lucira Health's COVID-19 & Flu Home Test

FDA Addresses 'Misinformation' Concerning Delayed Approval Of Lucira Health's COVID-19 & Flu Home Test
美国食品药品管理局解决了与延迟批准 Lucira Health 的 COVID-19 和流感家庭测试有关的 “错误信息”

Benzinga ·  03/11 00:55

The FDA provided additional information about the agency's interactions and decisions regarding the emergency use authorization (EUA) of Lucira Health Inc's (OTC: LHDXQ) COVID-19 & Flu Home test. The statement comes due to concerns about the agency's length and timing of the EUA clearance and its bankruptcy filing, which said the delay in EUA financially hit the company. In an investor report, Lucira blamed the FDA's "protracted" authorization process for its combination Covid and flu at-home test. Lucira applied to the FDA for authorization of its novel test last May and expected to receive

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