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  • Fact Sheet for Healthcare Providers: Vibrant COVID-19 Ab Assay -- Vibrant America Clinical Labs
    United States. Food and Drug Administration
    2020-06-04
  • Fact Sheet for Healthcare Providers: 'Hangzhou' Biotest Biotech Co., Ltd.; RightSign™ COVID-19 IgG/IgM Rapid Test Cassette
    United States. Food and Drug Administration
    2020-06-04
  • Development and Licensure of Vaccines to Prevent COVID-19: Guidance for Industry
    United States. Food and Drug Administration
    2020-06
  • Good Manufacturing Practice Considerations for Responding to COVID-19 Infection in Employees in Drug and Biological Products Manufacturing: 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.) . . .
    2020-06
  • Fact Sheet for Healthcare Personnel: Stryker Sustainability Solutions Decontamination System for Decontaminating Compatible N95 Respirators
    United States. Food and Drug Administration
    2020-05-27
  • FDA Combating COVID-19 with Medical Devices
    United States. Food and Drug Administration
    2020-05-25
  • Temporary Policy for Compounding of Certain Drugs for Hospitalized Patients by Outsourcing Facilities During the COVID-19 Public Health Emergency (Revised)
    United States. Food and Drug Administration
    2020-05-21
  • Memorandum of Understanding between FDA and USDA Regarding the Potential Use of the Defense Production Act with Regard to FDA-Regulated Food During the COVID-19 Pandemic
    United States. Food and Drug Administration
    2020-05-18
  • Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised): Immediately in Effect Guidance for Clinical Laboratories, Commercial Manufacturers, and Food and Drug Administration Staff
    United States. Food and Drug Administration
    2020-05-11
  • FDA Combating COVID-19 with Therapeutics
    United States. Food and Drug Administration
    2020-05-11
  • Fact Sheet for Healthcare Providers: Emergency Use of the Patient Isolation Transport Unit (PITU)
    United States. Food and Drug Administration
    2020-05-08
  • Fact Sheet for Healthcare Providers: Emergency Use of a Protective Barrier Enclosure During the COVID-19 Pandemic
    United States. Food and Drug Administration
    2020-05-01
  • Emergency Use Authorization: Face Masks
    United States. Food and Drug Administration
    Hinton, Denise M.
    2020-04-24
  • Fact Sheet for Healthcare Personnel: Sterilucent Sterilization System for Decontaminating Compatible N95 Respirators
    United States. Food and Drug Administration
    2020-04-20
  • FDA Guidance on Conduct of Clinical Trials of Medical Products During COVID-19 Pandemic: Guidance for Industry, Investigators, and Institutional Review Boards [Updated on April 16, 2020]
    United States. Food and Drug Administration
    2020-04-16
  • Investigational COVID-19 Convalescent Plasma: Guidance for Industry
    United States. Food and Drug Administration; United States. Department of Health and Human Services; Center for Biologics Evaluation and Research (U.S.)
    2020-04-13
  • Fact Sheet for Healthcare Providers: Emergency Use of the B. Braun Space and Outlook Pumps During the COVID-19 Pandemic
    United States. Food and Drug Administration
    2020-04-11
  • Fact Sheet for Healthcare Personnel: STERIS Sterilization Systems for Decontaminating Compatible N95 Respirators
    United States. Food and Drug Administration
    2020-04-09
  • Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products: Guidance for Industry
    United States. Department of Health and Human Services; United States. Food and Drug Administration; Center for Biologics Evaluation and Research (U.S.)
    2020-04
  • Blueprint for Testing Plans and Rapid Response Programs
    United States. White House Office; Centers for Disease Control and Prevention (U.S.); United States. Food and Drug Administration
    2020-04?
  • Enforcement Policy for Infusion Pumps and Accessories 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
    2020-04
  • Enforcement Policy for Remote Ophthalmic Assessment and Monitoring Devices During the Coronavirus Disease 2019 (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
    2020-04
  • Compra De Comestibles Durante La Pandemia Del COVID-19 - Información Para Los Consumidores
    United States. Food and Drug Administration
    2020-04
  • COVID-19 Information for Consumers -- Shopping for Food
    United States. Food and Drug Administration
    2020-04
  • What to Do If You Have COVID-19 Confirmed Positive or Exposed Workers in Your Food Production, Storage, or Distribution Operations Regulated by FDA
    United States. Food and Drug Administration
    2020-04
  • Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency (Revised)
    United States. Food and Drug Administration
    2020-04
  • [Letter from Denise M. Hinton to Manufacturers of Imported, Non-NIOSH-Approved Disposable Filtering Facepiece Respirators; Health Care Personnel; Hospital Purchasing Departments and Distributors; Importers and Commercial Wholesalers; and Any Other Applicable Stakeholders, March 28, 2020]
    United States. Food and Drug Administration
    Hinton, Denise M.
    2020-03-28
  • Policy for Diagnostic Tests for Coronavirus Disease-2019 During the Public Health Emergency: Immediately in Effect Guidance for Clinical Laboratories, Commercial Manufacturers, and Food and Drug Administration Staff
    United States. Food and Drug Administration
    2020-03-16
  • Fact Sheet for Healthcare Providers: New York SARS-CoV-2 Real-Time RT-PCR Diagnostic Panel
    United States. Food and Drug Administration
    2020-03-15
  • FDA Guidance on Conduct of Clinical Trials of Medical Products During COVID-19 Pandemic: Guidance for Industry, Investigators, and Institutional Review Boards
    United States. Food and Drug Administration
    2020-03
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