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  • Enforcement Policy for Gowns, Other Apparel, and Gloves During the Coronavirus Disease (COVID-19) Public Health Emergency: Guidance for Industry 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.)
    2020-03
  • Enforcement Policy for Sterilizers, Disinfectant Devices, and Air Purifiers 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; United States. Department of Health and Human Services; Center for Devices and Radiological Health (U.S.)
    2020-03
  • Enforcement Policy for Ventilators and Accessories and Other Respiratory Devices 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
    2020-03
  • Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency Immediately in Effect Guidance for Industry
    United States. Food and Drug Administration
    2020-03
  • Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19): Guidance for Industry
    United States. Department of Health and Human Services; United States. Food and Drug Administration; Center for Drug Evaluation and Research (U.S.)
    2020-03
  • Fact Sheet for Healthcare Providers: Molecular Laboratory Developed Test (LDT) COVID-19 Authorized Tests [SARS-CoV-2 RNA DETECTR Assay]
    United States. Food and Drug Administration
    2020?
  • Fact Sheet for Healthcare Providers: Molecular Laboratory Developed Test (LDT) COVID-19 Authorized Tests [Boston Heart COVID-19 RT-PCR Test]
    United States. Food and Drug Administration
    2020?
  • Fact Sheet for Healthcare Providers: Molecular Laboratory Developed Test (LDT) COVID-19 Authorized Tests [Acupath COVID-19 Real-Time (RT-PCR) Assay]
    United States. Food and Drug Administration
    2020?
  • Fact Sheet for Healthcare Providers Molecular Laboratory Developed Test (LDT) COVID-19 Authorized Tests [CRSP SARS-CoV-2 Real-Time Reverse Transcriptase (RT) PCR Diagnostic Assay]
    United States. Food and Drug Administration
    2020?
  • Fact Sheet for Healthcare Providers: Molecular Laboratory Developed Test (LDT) COVID-19 Authorized Tests [BMC-CReM COVID-19 Test]
    United States. Food and Drug Administration
    2020?
  • Fact Sheet for Healthcare Providers: Molecular Laboratory Developed Test (LDT) COVID-19 Authorized Tests [Gene By Gene SARS-CoV-2 Detection Test]
    United States. Food and Drug Administration
    2020?
  • Fact Sheet for Healthcare Providers: Molecular Laboratory Developed Test (LDT) COVID-19 Authorized Tests [Pro-AmpRT SARS-CoV-2 Test]
    United States. Food and Drug Administration
    2020?
  • Fact Sheet for Healthcare Providers: Molecular Laboratory Developed Test (LDT) COVID-19 Authorized Tests [Helix COVID-19 NGS Test]
    United States. Food and Drug Administration
    2020?
  • Fact Sheet for Healthcare Providers: Molecular Laboratory Developed Test (LDT) COVID-19 Authorized Tests [Alpha Genomix TaqPath SARS-CoV-2 Combo Assay]
    United States. Food and Drug Administration
    2020
  • Fact Sheet for Healthcare Providers: REGIOCIT: A Replacement Solution that Contains Citrate for Regional Citrate Anticoagulation (RCA) of the Extracorporeal Circuit
    United States. Food and Drug Administration
    2020?
  • Fact Sheet for Healthcare Providers: Molecular Laboratory Developed Test (LDT) COVID-19 Authorized Tests [GWU COVID-19 RT-PCR Test]
    United States. Food and Drug Administration
    2020?
  • Fact Sheet for Healthcare Providers: Molecular Laboratory Developed Test (LDT) COVID-19 Authorized Tests [Solaris Multiplex SARS-CoV-2 Assay]
    United States. Food and Drug Administration
    2020?
  • Fact Sheet for Healthcare Providers: Molecular Laboratory Developed Test (LDT) COVID-19 Authorized Tests [Texas Department of State Health Services (DSHS) SARS-CoV-2 Assay]
    United States. Food and Drug Administration
    2020?
  • Fact Sheet for Healthcare Providers: Molecular Laboratory Developed Test (LDT) COVID-19 Authorized Tests [Guardant-19 Test]
    United States. Food and Drug Administration
    2020?
  • Fact Sheet for Healthcare Providers: Molecular Laboratory Developed Test (LDT) COVID-19 Authorized Tests [SARS-CoV-2 Mass Array Test]
    United States. Food and Drug Administration
    2020?
  • Fact Sheet for Healthcare Providers: Molecular Laboratory Developed Test (LDT) COVID-19 Authorized Tests [Akron Children's Hospital SARS-CoV-2 Assay]
    United States. Food and Drug Administration
    2020?
  • Fact Sheet for Healthcare Providers: Molecular Laboratory Developed Test (LDT) COVID-19 Authorized Tests [Aeon Global Health SARS-CoV-2 Assay]
    United States. Food and Drug Administration
    2020?
  • FDA's Technology Modernization Action Plan (TMAP)
    United States. Food and Drug Administration
    2019-09-18
  • Foodborne Illness Source Attribution Estimates for 2017 for 'Salmonella,' 'Escherichia Coli O157,' 'Listeria Monocytogenes,' and 'Campylobacter' Using Multi-Year Outbreak Surveillance Data, United States
    Centers for Disease Control and Prevention (U.S.); United States. Food and Drug Administration; United States. Food Safety and Inspection Service
    Interagency Food Safety Analytics Collaboration
    2019-09
  • FDA Strategy for the Safety of Imported Food
    United States. Food and Drug Administration
    2019-02
  • Zika Virus Response Updates from FDA
    United States. Food and Drug Administration
    2018-08?
  • Biosimilars Action Plan: Balancing Innovation and Competition
    United States. Food and Drug Administration
    2018-07
  • Anthrax: Developing Drugs for Prophylaxis of Inhalational Anthrax, Guidance for Industry
    United States. Department of Health and Human Services; United States. Food and Drug Administration; Center for Drug Evaluation and Research (U.S.)
    2018-05
  • FDA Medical Countermeasures Initiative (MCMi): Fiscal Year 2018 Program Update
    United States. Food and Drug Administration
    2018
  • Zika Virus Vaccines and Therapeutics
    United States. Food and Drug Administration
    McArthur, Monica
    2017-04-13
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