Emergency Preparedness and Response
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Emergency Use Authorization--Archived Information
The Emergency Use Authorization1 (EUA) authority allows the FDA Commissioner to strengthen the public health protections against biological, chemical, radiological, and nuclear agents that may be used to attack the American people or the U.S. armed forces.
The lists below provide information on previously issued EUAs.
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H1N1: Antiviral EUA Information
Post H1N1 Public Health Emergency FDA EUA activity specific to Oseltamavir(Tamiflu), Zanamavir (Relenza), and Peramivir
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H1N1: Antiviral Medical Device EUA Information
Post H1N1 Public Health Emergency FDA EUA Activity Specific to In Vitro Diagnostic Tests
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H1N1 EUA Information
Expired Public Health Emergency Declarations and Terminated EUAs
Federal Register Notice of Public Health Emergency and Declaration-Expired (PDF - 52KB)Federal Register Notice announcing renewal of the Public Health Emergency and Declaration-Expired (PDF - 48KB)Peramivir EUA-NO LONGER IN EFFECT (PDF - 65KB)Amendment to Peramivir EUA-NO LONGER IN EFFECT (PDF - 55KB)Tamiflu and Relenza EUAs-NO LONGER IN EFFECT (PDF - 66KB)Amendment to Tamiflu and Relenza EUAs-NO LONGER IN EFFECT (PDF - 116KB)Personal Protective Equipment (PPE) EUA-NO LONGER IN EFFECT (PDF - 2MB)CDC Human Influenza Virus Real-time RT-PCR Detection and Characterization Panel with additional specimens and reagents-NO LONGER IN EFFECT (PDF - 76KB)CDC rRT-PCR Swine Flu Panel on the Joint Biological Agent Identification and Diagnostic System (JBAIDS) Instrument-NO LONGER IN EFFECT (PDF - 161KB)CDC Swine Influenza Virus Real-time RT-PCR Detection Panel-NO LONGER IN EFFECT (PDF - 161KB)Cepheid Xpert® Flu A Panel for the Diagnosis of 2009 H1N1 Influenza Virus Infection-NO LONGER IN EFFECT (PDF - 161KB)Diagnostic Hybrids, Inc. D3 Ultra 2009 H1N1 Influenza A Virus ID Kit-NO LONGER IN EFFECT (PDF - 139KB)Diatherix 2009 H1N1 Test-NO LONGER IN EFFECT (PDF - 161KB)ELITech Molecular Diagnostics 2009-H1N1 Influenza A virus Real-Time RT-PCR Test-NO LONGER IN EFFECT (PDF - 139KB)Focus Diagnostics Influenza A H1N1 (2009) Real-Time RT-PCR-NO LONGER IN EFFECT (PDF - 161KB)Focus Diagnostics Simplexa™ Influenza A H1N1 (2009) Test-NO LONGER IN EFFECT (PDF - 161KB)GeneSTAT 2009 A/H1N1 Influenza Test-NO LONGER IN EFFECT (PDF - 161KB)IMDx 2009 Influenza A H1N1 Real-Time RT-PCR Assay from IntelligentMDx-NO LONGER IN EFFECT (PDF - 139KB)IQuum Liat™ Influenza A/2009 H1N1 Assay-NO LONGER IN EFFECT (PDF - 139KB)Longhorn Influenza A/H1N1-09 Prime RRT-PCR Assay-NO LONGER IN EFFECT (PDF - 139KB)Prodesse ProFlu-ST Influenza A assay for the diagnosis of 2009 H1N1 Influenza virus infection-NO LONGER IN EFFECT (PDF - 161KB)Qiagen artus® Inf. A H1N1 2009 LC RT-PCR Kit-NO LONGER IN EFFECT (PDF - 139KB)Roche RealTime ready Influenza A/H1N1 Test-NO LONGER IN EFFECT (PDF - 161KB)TessArray Resequencing Influenza A Microarray Detection Panel-NO LONGER IN EFFECT (PDF - 161KB)ViraCor 2009 H1N1 Influenza A Real-time RT-PCR-NO LONGER IN EFFECT (PDF - 139KB)
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