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Lin mark this message contains misinformation
originally written by Lin
目前 FDA 尚未釋出停止 EUA 的消息,疫苗都經過嚴謹的測試,並非有疫苗錯失卻免責的狀況。美國 FDA 當初考量新冠病毒所爆發的公共衛生事件與公衛需求,祭出緊急使用授權制度,採納對於疫情有重大進展的新技術診斷產品,以及可解決未被滿足的醫療診斷產品,不過隨著疫情趨緩,FDA 逐步取消新冠檢測診斷產品的 EUA。

References

https://www.fda.gov/vaccines-blood-biologics/vaccines/emergency-use-authorization-vaccines-explained
Emergency Use Authorization for Vaccines Explained

https://tw.stock.yahoo.com/news/eua時代結束-台廠調整產品策略-重啟臨床-結合新項目-045314033.html

〈EUA時代結束〉台廠調整產品策略 重啟臨床、結合新項目

新冠疫情走向流感化,美國 FDA 準備將緊急使用授權 (EUA) 逐步退場,未來檢測診斷產品需要申請正規的 510(K) 認證,此舉將影響許多檢測開發商布局。

https://tw.stock.yahoo.com/news/eua%E6%99%82%E4%BB%A3%E7%B5%90%E6%9D%9F-%E5%8F%B0%E5%BB%A0%E8%AA%BF%E6%95%B4%E7%94%A2%E5%93%81%E7%AD%96%E7%95%A5-%E9%87%8D%E5%95%9F%E8%87%A8%E5%BA%8A-%E7%B5%90%E5%90%88%E6%96%B0%E9%A0%85%E7%9B%AE-045314033.html

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