Umbrella EUA | 合法醫療器材資訊網
2020年8月3日—CoronavirusDisease2019(COVID-19)EUA....forMolecularDiagnosticTestsforSARS-CoV-2;UmbrellaEUAforMolecularDiagnosticTests ...,AboutEmergencyUseAuthorizations(EUAs)·PREPAct·EUAGuidance·COVID-19EUAs.Vaccines;DrugandBiologicalTherapeuticProducts;InformationAbout ...,2020年5月1日—Thenewroute,describedbyFDAasan“umbrella”EUA,willenableserologyteststobemarketedafterbeingputthroughanindependent ...,FDAUpdatesListofAuthorizedVentilatorsunderUmbrellaEUA...TheFDAhasupdatedthelistofauthorizedv...
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Coronavirus Disease 2019 (COVID | 合法醫療器材資訊網
2020年8月3日 — Coronavirus Disease 2019 (COVID-19) EUA. ... for Molecular Diagnostic Tests for SARS-CoV-2; Umbrella EUA for Molecular Diagnostic Tests ... Read More
Emergency Use Authorization | 合法醫療器材資訊網
About Emergency Use Authorizations (EUAs) · PREP Act · EUA Guidance · COVID-19 EUAs. Vaccines; Drug and Biological Therapeutic Products; Information About ... Read More
FDA creates umbrella emergency pathway for COVID | 合法醫療器材資訊網
2020年5月1日 — The new route, described by FDA as an “umbrella” EUA, will enable serology tests to be marketed after being put through an independent ... Read More
FDA Updates List of Authorized Ventilators under Umbrella ... | 合法醫療器材資訊網
FDA Updates List of Authorized Ventilators under Umbrella EUA ... The FDA has updated the list of authorized ventilator, ventilator tubing connector, and ventilator ... Read More
FDA再度放寬新冠病毒血清抗體檢測上市途徑 | 合法醫療器材資訊網
2020年5月5日 — ... 更新了有關體外診斷試劑(IVD)之緊急使用授權(EUA)規定,新增適用於新冠肺炎血清抗體檢測的傘式緊急途徑(umbrella emergency pathway)。 Read More
In Vitro Diagnostics EUAs | 合法醫療器材資訊網
5 天前 — Umbrella EUA for Independently Validated Serology Tests for SARS-CoV-2. Individual EUAs for Serology and Other Adaptive Immune Response ... Read More
In Vitro Diagnostics EUAs | 合法醫療器材資訊網
2021年5月24日 — Any test developer requesting an EUA that intends to leverage data from ... to any entity seeking an FDA EUA for a COVID-19 diagnostic device. ... for Certain Molecular Diagnostic Tests for SARS-CoV-2 · Umbrella EUA for ... Read More
Personal Protective Equipment EUAs | 合法醫療器材資訊網
Umbrella EUA for Surgical Masks. On August 5, 2020, the FDA issued an umbrella emergency use authorization (EUA) for certain disposable, single-use surgical ... Read More
Ventilators and Ventilator Accessories EUAs | 合法醫療器材資訊網
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