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  • Resiliency Roadmap for FDA Inspectional Oversight
    United States. Food and Drug Administration
    2021-05
  • Emergency Use Authorization for Vaccines to Prevent COVID-19: Guidance for Industry [February 22, 2021]
    United States. Food and Drug Administration
    2021-02-22
  • Fact Sheet for Healthcare Providers Lumiradx UK Ltd., LumiraDx SARS-CoV-2 RNA STAR Complete
    United States. Food and Drug Administration
    2021-02-09
  • Policy for Evaluating Impact of Viral Mutations on COVID-19 Tests: Guidance for Test Developers and Food and Drug Administration Staff
    United States. Department of Health and Human Services; United States. Food and Drug Administration; Center for Devices and Radiological Health (U.S.)
    2021-02
  • Fact Sheet for Healthcare Providers: Access Bio, Inc., 'CareStart'™ COVID-19 Antigen
    United States. Food and Drug Administration
    2021-02-01
  • FDA COVID-19 Pandemic Recovery and Preparedness Plan (PREPP) Initiative: Summary Report
    United States. Food and Drug Administration
    2021-01
  • Methods for Evaluating the Opioid Analgesic Risk Evaluation and Mitigation Strategy
    Center for Drug Evaluation and Research (U.S.); United States. Food and Drug Administration; United States. Department of Health and Human Services
    2020-12-11
  • Vaccines and Related Biological Products Advisory Committee Meeting: Pfizer-BioNTech COVID-19 Vaccine
    United States. Food and Drug Administration
    2020-12-10
  • Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency: Guidance for Industry, Investigators, and Institutional Review Boards
    United States. Food and Drug Administration
    2020-12-04
  • Fact Sheet for Healthcare Providers: BioFire Diagnostics, LLC, BioFire® Respiratory Panel 2.1-EZ (RP2.1-EZ)
    United States. Food and Drug Administration
    2020-11-22
  • Fact Sheet for Healthcare Providers: Agena Bioscience, Inc., MassARRAY SARS-CoV-2 Panel
    United States. Food and Drug Administration
    2020-10-26
  • Fact Sheet for Healthcare Providers: Celltrion USA, Inc., Sampinute™ 'COVID-19 Antigen MIA'
    United States. Food and Drug Administration
    2020-10-23
  • FDA Briefing Document: Development, Authorization and Licensure of Vaccines to Prevent COVID-19
    United States. Food and Drug Administration
    2020-10-22
  • Fact Sheet for Healthcare Personnel: Zoe-Ann Decontamination System for Decontaminating Compatible N95 Respirators
    United States. Food and Drug Administration
    2020-10-20
  • Fact Sheet for Healthcare Providers: Abbott Laboratories, AdviseDx SARS-CoV-2 IgM
    United States. Food and Drug Administration
    2020-10-09
  • Fact Sheet for Healthcare Providers: Beckman Coulter, Inc., Access SARS‐CoV‐2 IgM
    United States. Food and Drug Administration
    2020-10-08
  • Fact Sheet for Healthcare Providers: Genalyte, Inc., Maverick SARS-CoV-2 Multi-Antigen Serology Panel v2
    United States. Food and Drug Administration
    2020-10-08
  • Fact Sheet for Healthcare Providers: ePlex® Respiratory Pathogen Panel 2, GenMark Diagnostics, Inc.
    United States. Food and Drug Administration
    2020-10-07
  • Fact Sheet for Healthcare Providers: University of California, Los Angeles (UCLA), UCLA SwabSeq COVID-19 Diagnostic Platform
    United States. Food and Drug Administration
    2020-10-06
  • Fact Sheet for Healthcare Providers: Zeus Scientific, Inc., ZEUS ELISA SARS-CoV-2 IgG Test System
    United States. Food and Drug Administration
    2020-10-06
  • Fact Sheet for Healthcare Providers: Seasun Biomaterials Inc, AQ-TOP COVID-19 Rapid Detection Kit PLUS
    United States. Food and Drug Administration
    2020-10-05
  • Fact Sheet for Healthcare Providers: Quidel Corporation, Sofia 2 Flu + SARS Antigen FIA
    United States. Food and Drug Administration
    2020-10-02
  • Fact Sheet for Healthcare Providers: Thermo Fisher Scientific, OmniPATH COVID-19 Total Antibody ELISA Test
    United States. Food and Drug Administration
    2020-10-02
  • Fact Sheet for Healthcare Providers: DetectaChem Inc, MobileDetect Bio BCC19 Test Kit
    United States. Food and Drug Administration
    2020-10-02
  • Emergency Use Authorization for Vaccines to Prevent COVID-19: Guidance for Industry
    United States. Food and Drug Administration
    2020-10
  • Fact Sheet for Healthcare Providers: Cepheid, Xpert Xpress SARS-CoV-2/Flu/RSV
    United States. Food and Drug Administration
    2020-10-01
  • Fact Sheet for Healthcare Providers: Tempus Labs, Inc., iC SARS-CoV2 Test
    United States. Food and Drug Administration
    2020-10-01
  • Fact Sheet for Healthcare Providers: Access IL-6 - Beckman Coulter, Inc.
    United States. Food and Drug Administration
    2020-10-01
  • Enforcement Policy for Modifications to FDA-Cleared Molecular Influenza and RSV Tests During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency: Guidance for Industry and Food and Drug Administration Staff
    United States. Food and Drug Administration
    2020-10
  • Fact Sheet for Healthcare Providers: Nirmidas Biotech, Inc., Nirmidas COVID-19 (SARS-CoV-2) IgM/IgG Antibody Detection Kit
    United States. Food and Drug Administration
    2020-09-29
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