中國先鋒醫藥(01345.HK):美國食品藥品監督管理局展開檢測試劑盒緊急情況前使用授權流程
格隆匯6月4日丨中國先鋒醫藥(01345.HK)發佈公告,美國食品藥品監督管理局近期就有關新型冠狀病毒(SARS-CoV-2)IgG/IgM聯合抗體檢測試劑盒(免疫螢光層析法)展行緊急情況前使用授權流程。
檢測試劑盒為深圳市邁科龍技術有限公司產品,該公司為一間於中國註冊成立的公司,其及其股東為獨立於公司及其關連人士的第三方。集團自2020年起,擔任深圳邁科龍現正開發的多類新型冠狀病毒(SARS-CoV-2)檢測試劑盒的美國獨家代理,為期10年。
緊急情況前使用授權流程允許食品藥品監督管理局的科學及技術事宜專家展開資料審閲,並於緊急情況前協助制定緊急情況使用授權的授權條件、情況説明及所需的其他文件,以及幫助於當前緊急聲明期間推進完成緊急情況使用授權的要求。緊急情況使用授權允許食品藥品監督管理局授權,於預計可能出現緊急情況或實際緊急情況期間使用未經批准的醫療防護措施。若干新冠病毒檢測試劑盒的緊急情況前使用授權流程
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