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Collection: Global Health Events web archive
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Group: Coronavirus disease (COVID-19) outbreak
Creator: Winchester Star, Gratzer, Earl
Language: English
Type: Letter
Collector: National Library of Medicine (U.S.)
Keyword: Vaccines, Vulnerable Populations, Migrants, Prevention and Control/Risk Management
Collection: Global Health Events web archive
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States. Office of Management and Budget, White House (Washington, D.C.), United States. President (2021- : Biden)
Language: English
Type: Letter
Geographic Location: Ukraine
Collector: National Library of Medicine (U.S.)
Keyword: Prevention and Control/Risk Management, Social Dimensions
Collection: Global Health Events web archive
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Group: Coronavirus disease (COVID-19) outbreak
Creator: Well and Good, Onyejiaka, Tiffany
Language: English
Type: Letter
Collector: National Library of Medicine (U.S.)
Keyword: Scientists in the Public Eye/Scientific Advisors, Vaccines, Kizzmekia Corbett, Biomedical Research
Collection: Global Health Events web archive
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Group: Coronavirus disease (COVID-19) outbreak
Creator: Downey Patriot, Montero, Jorge
Language: English
Type: Letter
Collector: National Library of Medicine (U.S.)
Keyword: Biomedical Research, Vaccines, Bioethics, Personal Narratives
Collection: Global Health Events web archive
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Group: Coronavirus disease (COVID-19) outbreak
Creator: The Bedford Citizen
Language: English
Type: Letter
Geographic Location: New Jersey
Collector: National Library of Medicine (U.S.)
Keyword: Social Dimensions, Vaccines, Non-compliance, Misinformation, Education
Collection: Global Health Events web archive
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Group: Coronavirus disease (COVID-19) outbreak
Creator: Atlantic Monthly Press
Language: English
Type: Letter
Collector: National Library of Medicine (U.S.)
Keyword: Personal Narratives
Collection: Global Health Events web archive
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Group: Coronavirus disease (COVID-19) outbreak
Creator: Tayba Foundation, Nsour, Rami
Language: English
Type: Letter
Collector: National Library of Medicine (U.S.)
Keyword: Vulnerable Populations, Prisoners
Collection: Global Health Events web archive
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Group: Coronavirus disease (COVID-19) outbreak
Creator: Austin American-Statesman (Firm)
Language: English
Type: Letter
Geographic Location: Texas
Collector: National Library of Medicine (U.S.)
Keyword: Prevention and Control/Risk Management, Social Dimensions
Collection: Global Health Events web archive
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Group: Coronavirus disease (COVID-19) outbreak
Creator: Shreveport Times
Language: English
Type: Letter
Geographic Location: Louisiana
Collector: National Library of Medicine (U.S.)
Keyword: Vulnerable Populations, Disaster Victims, Legislation and Jurisprudence, Social Dimensions
Collection: Global Health Events web archive
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Group: Coronavirus disease (COVID-19) outbreak
Creator: Gannett Company, Register-Guard
Language: English
Type: Letter
Geographic Location: Oregon
Collector: National Library of Medicine (U.S.)
Keyword: Vaccines, Vulnerable Populations, Prevention and Control/Risk Management, Caregiving, Non-medical Essential Workers, Education, Elderly, Social Dimensions
Collection: Global Health Events web archive
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Group: Coronavirus disease (COVID-19) outbreak
Creator: Portland Press Herald
Language: English
Type: Letter
Collector: National Library of Medicine (U.S.)
Collection: Global Health Events web archive
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Group: Coronavirus disease (COVID-19) outbreak
Creator: Evening Post Publishing Company (Charleston, S.C.)
Language: English
Type: Letter
Collector: National Library of Medicine (U.S.)
Keyword: Social Dimensions, Vaccines, Misinformation
Collection: Global Health Events web archive
Description: "Peace Corps announces suspension of Volunteer activities, evacuations due to COVID-19". Open letter from Director Jody Olsen dated 15 March 2020. Peace Corps is suspending all volunteer activities and evacuating volunteers.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: Peace Corps (U.S.), Olsen, Jody K.
Language: English
Type: Letter
Collector: National Library of Medicine (U.S.)
Keyword: Prevention and Control/Risk Management, Social Dimensions
Collection: Global Health Events web archive
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Group: Coronavirus disease (COVID-19) outbreak
Creator: Patient Access Network Foundation, Klein, Dan
Language: English
Type: Letter
Collector: National Library of Medicine (U.S.)
Keyword: Vulnerable Populations, Pre-existing Medical Conditions, Socioeconomically Disadvantaged, Legislation and Jurisprudence
Collection: Global Health Events web archive
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Group: Coronavirus disease (COVID-19) outbreak
Creator: Gannett Company, Palm Beach Post
Language: English
Type: Letter
Collector: National Library of Medicine (U.S.)
Keyword: Prevention and Control/Risk Management, Social Dimensions, Vaccines, Non-compliance
Collection: Global Health Events web archive
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Group: Coronavirus disease (COVID-19) outbreak
Creator: New York Times Company
Language: English
Type: Letter
Collector: National Library of Medicine (U.S.)
Keyword: Psychological Preparedness and Responses, Education, Social Dimensions
Collection: Global Health Events web archive
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Group: Coronavirus disease (COVID-19) outbreak
Creator: Northern Virginia Daily, Yang, Leonard
Language: English
Type: Letter
Collector: National Library of Medicine (U.S.)
Keyword: Prevention and Control/Risk Management, Health Policy Advocacy, Misinformation
Collection: Global Health Events web archive
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Group: Coronavirus disease (COVID-19) outbreak
Creator: International Council of Nurses, Kennedy, Annette
Language: English
Type: Letter
Collector: National Library of Medicine (U.S.)
Keyword: Health Workforce
Collection: Global Health Events web archive
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Group: Coronavirus disease (COVID-19) outbreak
Creator: Parkersburg News and Sentinel, Hickman, Paul
Language: English
Type: Letter
Geographic Location: Alaska, West Virginia
Collector: National Library of Medicine (U.S.)
Keyword: Patient Treatment and Experience, Personal Narratives, Vulnerable Populations
Collection: Global Health Events web archive
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Group: Coronavirus disease (COVID-19) outbreak
Creator: National Down Syndrome Society (U.S.), Pickard, Kandi
Language: English
Type: Letter
Collector: National Library of Medicine (U.S.)
Keyword: Vaccines, Vulnerable Populations, Prevention and Control/Risk Management, Disability/Disabled Persons
Collection: Global Health Events web archive
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Group: Coronavirus disease (COVID-19) outbreak
Creator: National Academies of Sciences, Engineering, and Medicine (U.S.)
Language: English
Type: Letter
Collector: National Library of Medicine (U.S.)
Keyword: Prevention and Control/Risk Management, Social Dimensions
Collection: Global Health Events web archive
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Group: Coronavirus disease (COVID-19) outbreak
Creator: Morning Journal News
Language: English
Type: Letter
Geographic Location: U.S. Southern Border
Collector: National Library of Medicine (U.S.)
Keyword: Vaccines, Social Dimensions
Collection: Global Health Events web archive
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Group: Coronavirus disease (COVID-19) outbreak
Creator: Moose Jaw Today, Miller, Fran
Language: English
Type: Letter
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease, Social Dimensions, Education, Non-compliance
Collection: Global Health Events web archive
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Group: Coronavirus disease (COVID-19) outbreak
Creator: Advance Local Media, LLC, MLive
Language: English
Type: Letter
Geographic Location: Michigan
Collector: National Library of Medicine (U.S.)
Keyword: Prevention and Control/Risk Management, Social Dimensions, Vaccines
Collection: Global Health Events web archive
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Group: Coronavirus disease (COVID-19) outbreak
Creator: Advance Local Media, LLC, MLive, Hiner, John
Language: English
Type: Letter
Geographic Location: Michigan
Collector: National Library of Medicine (U.S.)
Keyword: Prevention and Control/Risk Management, Social Dimensions, Non-compliance
Collection: Global Health Events web archive
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Group: Coronavirus disease (COVID-19) outbreak
Creator: Mercury News, Phillips, Jeanne
Language: English
Type: Letter
Collector: National Library of Medicine (U.S.)
Keyword: Patient Treatment and Experience, Tracking the Disease, Social Dimensions
Collection: Global Health Events web archive
Description: Open Letter to Dr. Francis Collins, Director, National Institutes of Health, on including pregnant and lactating women in all research for the development of vaccines and therapeutics related to COVID-19
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Group: Coronavirus disease (COVID-19) outbreak
Creator: March of Dimes Birth Defects Foundation, Coalition to Advance Maternal Therapeutics
Language: English
Type: Letter
Collector: National Library of Medicine (U.S.)
Keyword: Biomedical Research, Social Dimensions, Vaccines
Collection: Global Health Events web archive
Description: "Final Letter to Administration Re: PPE" Dated 03 April 2020.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: American Lung Association
Language: English
Type: Letter
Collector: National Library of Medicine (U.S.)
Keyword: Prevention and Control/Risk Management, Health Workforce
Collection: Global Health Events web archive
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Group: Coronavirus disease (COVID-19) outbreak
Creator: American Lung Association
Language: English
Type: Letter
Collector: National Library of Medicine (U.S.)
Keyword: Vulnerable Populations, Pre-existing Medical Conditions, Legislation and Jurisprudence, Prevention and Control/Risk Management
Collection: Global Health Events web archive
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Group: Coronavirus disease (COVID-19) outbreak
Creator: American Lung Association, Wimmer, Harold P.
Language: English
Type: Letter
Collector: National Library of Medicine (U.S.)
Keyword: Vulnerable Populations, Pre-existing Medical Conditions, Biomedical Research, Patient Treatment and Experience
Collection: Global Health Events web archive
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Group: Coronavirus disease (COVID-19) outbreak
Creator: Lifewire, Krinsky, Rachel
Language: English
Type: Letter
Collector: National Library of Medicine (U.S.)
Keyword: Vulnerable Populations, Victims of Abuse
Collection: Global Health Events web archive
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Group: Coronavirus disease (COVID-19) outbreak
Creator: Mary Ann Liebert, Inc., Valicenti-McDermott, Maria, Rivelis, Erin, Bernstein, Carla, Cardin, Marie Joane
Language: English
Type: Letter
Collector: National Library of Medicine (U.S.)
Keyword: Vulnerable Populations, Disability/Disabled Persons, Psychological Preparedness and Responses, Children
Collection: Global Health Events web archive
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Group: Coronavirus disease (COVID-19) outbreak
Creator: Los Angeles Times (Firm), Hanna, Elizabeth, Nock, Kerry T.
Language: English
Type: Letter
Collector: National Library of Medicine (U.S.)
Keyword: Health Workforce, Non-compliance, Misinformation, Social Dimensions
Collection: Global Health Events web archive
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Group: Coronavirus disease (COVID-19) outbreak
Creator: Los Angeles Times (Firm)
Language: English
Type: Letter
Collector: National Library of Medicine (U.S.)
Keyword: Vulnerable Populations, Children, Vaccines, Non-medical Essential Workers
Collection: Global Health Events web archive
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Group: Mpox (monkeypox) outbreak 2022
Creator: La Salle University, Cook, R. Scott
Language: English
Type: Letter
Geographic Location: Pennsylvania
Collector: National Library of Medicine (U.S.)
Keyword: Basic Information
Collection: Global Health Events web archive
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Group: Coronavirus disease (COVID-19) outbreak
Creator: Island Packet
Language: English
Type: Letter
Geographic Location: South Carolina
Collector: National Library of Medicine (U.S.)
Keyword: Prevention and Control/Risk Management, Non-compliance, Social Dimensions
Collection: Global Health Events web archive
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Group: Coronavirus disease (COVID-19) outbreak
Creator: Gannett Company, Indianapolis Star
Language: English
Type: Letter
Geographic Location: Indiana
Collector: National Library of Medicine (U.S.)
Keyword: Prevention and Control/Risk Management, Vaccines, Social Dimensions
Collection: Global Health Events web archive
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Group: Coronavirus disease (COVID-19) outbreak
Creator: Gannett Company, Hutchinson News, Vogel, Stanley J.
Language: English
Type: Letter
Collector: National Library of Medicine (U.S.)
Keyword: Bioethics, Vaccines, Biomedical Research
Collection: Global Health Events web archive
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Group: Coronavirus disease (COVID-19) outbreak
Creator: Herald Journal (Firm), Shepherd, Mollie
Language: English
Type: Letter
Collector: National Library of Medicine (U.S.)
Keyword: Social Dimensions, Education, Personal Narratives, Non-medical Essential Workers
Collection: Global Health Events web archive
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Group: Mpox (monkeypox) outbreak 2022
Creator: Harlem United Community Aids Center, Martin-Udry, Maya
Language: English
Type: Letter
Geographic Location: New York
Collector: National Library of Medicine (U.S.)
Keyword: Vaccines, Prevention and Control/Risk Management, Social Dimensions
Collection: Global Health Events web archive
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Group: Mpox (monkeypox) outbreak 2022
Creator: Gay Men’s Health Crisis, Inc., Harlem United Community Aids Center, Callen-Lorde Community Health Center, Apicha Community Health Center, Translatinx Netowrk, Latino Commission on AIDS
Language: English
Type: Letter
Geographic Location: New York
Collector: National Library of Medicine (U.S.)
Keyword: Vaccines, Health Disparities, Geography, Sexual Orientation
Collection: Global Health Events web archive
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Group: Coronavirus disease (COVID-19) outbreak
Creator: Gay, Lesbian, and Straight Education Network, Byard, Eliza
Language: English
Type: Letter
Collector: National Library of Medicine (U.S.)
Keyword: Vulnerable Populations, Children, Health Disparities, Sexual Orientation
Collection: Global Health Events web archive
Description: This letter alerts health care providers (HCP) and health care facilities that the use of passive protective barrier enclosures (those without negative pressure) when treating patients who are known or suspected to have coronavirus disease 2019 (COVID-19) may pose an increased health risk to patients and HCPs, and provides recommendations.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration, Division of Industry and Consumer Education
Language: English
Type: Letter
Collector: National Library of Medicine (U.S.)
Keyword: Health Workforce
Collection: Global Health Events web archive
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States. Food and Drug Administration, O'Saughnessy, Jacqueline A.
Language: English
Type: Letter
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease, Adapting Technology
Collection: Global Health Events web archive
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States. Food and Drug Administration, O'Shaughnessy, Jacqueline A.
Language: English
Type: Letter
Collector: National Library of Medicine (U.S.)
Keyword: Patient Treatment and Experience, Prevention and Control/Risk Management
Collection: Global Health Events web archive
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States. Food and Drug Administration, Hinton, Denise M.
Language: English
Type: Letter
Collector: National Library of Medicine (U.S.)
Keyword: Patient Treatment and Experience
Collection: Global Health Events web archive
Description: This letter authorizes the emergency use of the binx health At-Home Nasal Swab COVID-19 Sample Collection Kit. The kit is for use by individuals for self-collection of nasal swab specimens at home, when determined by a healthcare provider to be appropriate based on the results of an online COVID-19 questionnaire and for use only with an in vitro diagnostic (IVD) molecular test for the detection of SARS-CoV-2 RNA that is indicated for use with the binx health At-Home Nasal Swab COVID-19 Sample Collection Kit.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration, Jones, Marc, Hinton, Denise M.
Language: English
Type: Letter
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
Collection: Global Health Events web archive
Description: This letter authorizes the emergency use of the EmpowerDX At-Home COVID-19 PCR Test Kit for use by individuals to self-collect nasal swabs at home, when determined by a healthcare provider to be appropriate based on the results of an online COVID-19 questionnaire, and for use only with in vitro diagnostic (IVD) molecular tests for the detection of SARS-CoV-2 RNA that are indicated for use with the EmpowerDX At-Home COVID-19 PCR Test Kit.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration, Lunn, Randee K., Hinton, Denise M.
Language: English
Type: Letter
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
Collection: Global Health Events web archive
Description: This eight-page letter details the Emergency Use Authorization (EUA) for the UCSD RC SARS-CoV-2 Assay for qualitative detection of nucleic acid from SARS-CoV-2 in clinician-instructed self-collected nasal swab specimens (collected on site), and clinician-collected upper respiratory specimens (nasopharyngeal, mid-turbinate, anterior nares or oropharyngeal swab specimens) collected from individuals suspected of COVID-19 by their healthcare provider. This test is also for the qualitative detection of nucleic acid from the SARS-CoV-2 in pooled samples.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration, Pride, David T., Hinton, Denise M.
Language: English
Type: Letter
Collector: National Library of Medicine (U.S.)
Keyword: Basic Information, Biomedical Research
Collection: Global Health Events web archive
Description: This seven-page letter authorizes the use of this home collection kit by individuals to self-collect nasal swab specimens at home, video-observed by a heathcare provider, when determined by a healthcare provider to be appropriate based on results of a COVID-19 questionnaire, and for use only with in vitro diagnostic (IVD) molecular tests for the detection of SARS-CoV-2 RNA that are indicated for use with the Kroger Health COVID-19 Test Home Collection Kit.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration, Kirby, Jim, Hinton, Denise M.
Language: English
Type: Letter
Collector: National Library of Medicine (U.S.)
Keyword: Basic Information, Biomedical Research
Collection: Global Health Events web archive
Description: This seven-page letter details the Emergency Use Authorization (EUA) for the Inform Diagnostics SARS-CoV-2 RT-PCR Assay for qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal, oropharyngeal, anterior nasal, and mid-turbinate nasal swabs, as well as nasopharyngeal wash/aspirate or nasal aspirates, and bronchoalveolar lavage (BAL) specimens from individuals suspected of COVID-19 by their healthcare provider.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration, Wang, Yun, Hinton, Denise M.
Language: English
Type: Letter
Collector: National Library of Medicine (U.S.)
Keyword: Basic Information, Biomedical Research
Collection: Global Health Events web archive
Description: This seven-page letter details the Emergency Use Authorization (EUA) for the DSL COVID-19 Assay for qualitative detection of nucleic acid from SARS-CoV-2 in upper respiratory specimens (such as nasal, mid-turbinate, nasopharyngeal, and oropharyngeal swabs) and bronchioalveolarlavage (BAL) specimens from individuals suspected of COVID-19 by their healthcare provider.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration, Hoffman, Tony, Hinton, Denise M.
Language: English
Type: Letter
Collector: National Library of Medicine (U.S.)
Keyword: Basic Information, Biomedical Research
Collection: Global Health Events web archive
Description: This seven-page letter details the Emergency Use Authorization (EUA) for the HealthQuest Esoterics TaqPath SARS-CoV-2 Assay for qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal swab, oropharyngeal swab, anterior nasal swab, mid-turbinate nasal swab, nasopharyngeal wash/aspirate, nasal aspirate, and bronchoalveolar lavage specimens from individuals suspected of COVID-19 by their healthcare provider.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration, White, Jerry, Hinton, Denise M.
Language: English
Type: Letter
Collector: National Library of Medicine (U.S.)
Keyword: Basic Information, Biomedical Research
Collection: Global Health Events web archive
Description: This seven-page letter details the Emergency Use Authorization (EUA) for the FRL SARS CoV-2 Test for qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal swab, oropharyngeal swab, anterior nasal swab, mid-turbinate nasal swab, nasopharyngeal wash/aspirate, nasal aspirate, and bronchoalveolar lavage specimens from individuals suspected of COVID-19 by their healthcare provider.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration, Leal, Sixto M. Jr., Hinton, Denise M.
Language: English
Type: Letter
Collector: National Library of Medicine (U.S.)
Keyword: Basic Information, Biomedical Research
Collection: Global Health Events web archive
Description: This seven-page letter, updated on June 22, 2020, authorizes the emergency use of the COVID-19 Airway Management Isolation Chamber. This device is authorized for use by healthcare providers (HCP) as an extra layer of barrier protection in addition to personal protective equipment (PPE) to prevent HCP exposure to pathogenic biological airborne particulates during transport of patients, at the time of definitive airway management, or when performing medical procedures on such patients during the COVID-19 pandemic.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration, Paxton, Mark S., Hinton, Denise M.
Language: English
Type: Letter
Collector: National Library of Medicine (U.S.)
Keyword: Basic Information, Biomedical Research
Collection: Global Health Events web archive
Description: This seven-page letter details the Emergency Use Authorization (EUA) for the Omni COVID-19 Assay by RT-PCR for qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal swab, oropharyngeal swab, anterior nasal swab, mid-turbinate nasal swab, nasopharyngeal wash/aspirate, nasal aspirate, and bronchoalveolar lavage specimens from individuals suspected of COVID-19 by their healthcare provider.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration, Kamal, Mohammad, Hinton, Denise M.
Language: English
Type: Letter
Collector: National Library of Medicine (U.S.)
Keyword: Basic Information, Biomedical Research
Collection: Global Health Events web archive
Description: This seven-page letter details the Emergency Use Authorization (EUA) for the OSUWMC (Ohio State University Wexner Medical Center) COVID-19 RT-PCR test for qualitative detection of nucleic acid from SARS-CoV-2 in nasal, oropharyngeal (OP), and nasopharyngeal (NP) swab specimens from individuals suspected of COVID-19 by their healthcare provider.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration, Pancholi, Preeti, Hinton, Denise M.
Language: English
Type: Letter
Collector: National Library of Medicine (U.S.)
Keyword: Basic Information, Biomedical Research
Collection: Global Health Events web archive
Description: This three-page letter, issued on June 16, 2020, is notification of the revocation of the Emergency Use Authorization for the DPP COVID-19 IgM/IgG System, which received an Emergency Use Authorization from the Food and Drug Administration on April 14, 2020.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration, Sigismondi, Louise M., Hinton, Denise M.
Language: English
Type: Letter
Collector: National Library of Medicine (U.S.)
Keyword: Basic Information, Biomedical Research
Collection: Global Health Events web archive
Description: This 15-page document provides a memorandum explaining the basis for revocation of the Emergency Use Authorization for Emergency Use of Chloroquine Phosphate and Hydroxychloroquine Sulfate, effective June 15, 2020.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration, Disbrow, Gary L., Hinton, Denise M.
Language: English
Type: Letter
Collector: National Library of Medicine (U.S.)
Keyword: Basic Information, Biomedical Research
Collection: Global Health Events web archive
Description: This one-page letter authorizes the emergency use of the Corneum SARS-CoV-2 Assay, which is eligible for authorization under the March 31, 2020, Emergency Use Authorization (EUA) for Molecular-based Laboratory Developed Tests for Detection of Nucleic Acid from SARS-CoV-2 (Molecular LDT COVID-19 Authorized Test).
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration, Vigerust, David, Scherf, Uwe
Language: English
Type: Letter
Collector: National Library of Medicine (U.S.)
Keyword: Basic Information, Biomedical Research
Collection: Global Health Events web archive
Description: This one-page letter authorizes the emergency use of the Warrior Diagnostics SARS-CoV-2 Assay, which is eligible for authorization under the March 31, 2020, Emergency Use Authorization (EUA) for Molecular-based Laboratory Developed Tests for Detection of Nucleic Acid from SARS-CoV-2 (Molecular LDT COVID-19 Authorized Test).
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration, Doss, Megan, Scherf, Uwe
Language: English
Type: Letter
Collector: National Library of Medicine (U.S.)
Keyword: Basic Information, Biomedical Research
Collection: Global Health Events web archive
Description: This one-page letter authorizes the emergency use of the CSI SARS-CoV-2 RT PCR test, which is eligible for authorization under the March 31, 2020, Emergency Use Authorization (EUA) for Molecular-based Laboratory Developed Tests for Detection of Nucleic Acid from SARS-CoV-2 (Molecular LDT COVID-19 Authorized Test).
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration, Goudy, Kevin, Scherf, Uwe
Language: English
Type: Letter
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
Collection: Global Health Events web archive
Description: This one-page letter authorizes the emergency use of the Avera Institute for Human Genetics SARS-CoV-2 Assay, which is eligible for authorization under the March 31, 2020, Emergency Use Authorization (EUA) for Molecular-based Laboratory Developed Tests for Detection of Nucleic Acid from SARS-CoV-2 (Molecular LDT COVID-19 Authorized Test).
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration, Ehli, Erik, Scherf, Uwe
Language: English
Type: Letter
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
Collection: Global Health Events web archive
Description: This one-page letter authorizes the emergency use of the Exact Sciences SARS-CoV-2 (N gene detection) test, which is eligible for authorization under the March 31, 2020, Emergency Use Authorization (EUA) for Molecular-based Laboratory Developed Tests for Detection of Nucleic Acid from SARS-CoV-2 (Molecular LDT COVID-19 Authorized Test).
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration, Laffin, Jennifer, Hinton, Denise M.
Language: English
Type: Letter
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
Collection: Global Health Events web archive
Description: This eight-page letter of authorization details the Emergency Use Authorization (EUA) issued in response to concerns relating to insufficient supply and availability of gowns and other apparel for use by healthcare personnel (HCP) as personal protective equipment (PPE) for use in healthcare settings in accordance with Centers for Disease Control and Prevention (CDC) recommendations to protect both HCP and patients from the transfer of SARS-CoV-2, which causes COVID-19, in low or minimal risk level situations to prevent the spread of COVID-19.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration, Hinton, Denise M.
Language: English
Type: Letter
Collector: National Library of Medicine (U.S.)
Keyword: Prevention and Control/Risk Management, Health Facilities
Collection: Global Health Events web archive
Description: This one-page letter authorizes the emergency use of the Color SARS-CoV-2 LAMP Diagnostic Assay, which is eligible for authorization under the March 31, 2020, Emergency Use Authorization (EUA) for Molecular-based Laboratory Developed Tests for Detection of Nucleic Acid from SARS-CoV-2 (Molecular LDT COVID-19 Authorized Test).
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration, Zhou, Alicia Y., Hinton, Denise M.
Language: English
Type: Letter
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
Collection: Global Health Events web archive
Description: This seven-page letter details the Emergency Use Authorization for the Everlywell COVID-19 Test Home Collection Kit, which is intended to facilitate self-collection of nasal swab specimens at home by individuals when determined by a healthcare provider to be appropriate based on results of a COVID-19 questionnaire.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration, Kwo, Liz, Shuren, Jeffery E.
Language: English
Type: Letter
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
Collection: Global Health Events web archive
Description: This one-page letter authorizes the emergency use of the One Health Laboratories SARS-CoV-2 Real-Time RT-PCR Test, which is eligible for authorization under the March 31, 2020, Emergency Use Authorization (EUA) for Molecular-based Laboratory Developed Tests for Detection of Nucleic Acid from SARS-CoV-2 (Molecular LDT COVID-19 Authorized Test).
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration, Sewell, Brianna, Scherf, Uwe
Language: English
Type: Letter
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
Collection: Global Health Events web archive
Description: This one-page letter authorizes the emergency use of the Triplex CII-SARS-CoV-2 rRT-PCR Test, which is eligible for authorization under the March 31, 2020, Emergency Use Authorization (EUA) for Molecular-based Laboratory Developed Tests for Detection of Nucleic Acid from SARS-CoV-2 (Molecular LDT COVID-19 Authorized Test).
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration, Mishra, Nischay, Scherf, Uwe
Language: English
Type: Letter
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
Collection: Global Health Events web archive
Description: This one-page letter authorizes the emergency use of the Biocollections Worldwide SARS-CoV-2 Assay, which is eligible for authorization under the March 31, 2020, Emergency Use Authorization (EUA) for Molecular-based Laboratory Developed Tests for Detection of Nucleic Acid from SARS-CoV-2 (Molecular LDT COVID-19 Authorized Test).
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Letter
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
Collection: Global Health Events web archive
Description: This one-page letter authorizes the emergency use of the UTHSC/UCH SARS-CoV-2-RT-PCR Assay, which is eligible for authorization under the March 31, 2020, Emergency Use Authorization (EUA) for Molecular-based Laboratory Developed Tests for Detection of Nucleic Acid from SARS-CoV-2 (Molecular LDT COVID-19 Authorized Test).
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration, Hodge, Tim, Scherf, Uwe
Language: English
Type: Letter
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
Collection: Global Health Events web archive
Description: The Food and Drug Administration (FDA) updated this Emergency Use Authorization (EUA) on October 1, 2020, to permit the emergency use of the unapproved product remdesivir for treatment of suspected or laboratory confirmed coronavirus disease 2019 (COVID-19) in adults and children hospitalized with severe disease. The FDA approved remdesivir for the treatment of COVID-19 requiring hospitalization on October 22, 2020.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration, Low, Madelyn, O'Shaughnessy, Jacqueline A.
Language: English
Type: Letter
Collector: National Library of Medicine (U.S.)
Keyword: Patient Treatment and Experience, Biomedical Research
Collection: Global Health Events web archive
Description: This one-page letter authorizes the emergency use of the Altru Dx SARS-CoV-2 Assay, which is eligible for authorization under the March 31, 2020, Emergency Use Authorization (EUA) for Molecular-based Laboratory Developed Tests for Detection of Nucleic Acid from SARS-CoV-2 (Molecular LDT COVID-19 Authorized Test).
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration, Rakhade, Mrudula, Scherf, Uwe
Language: English
Type: Letter
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
Collection: Global Health Events web archive
Description: This one-page letter authorizes the emergency use of the Biocerna SARS-CoV-2 Assay, which is eligible for authorization under the March 31, 2020, Emergency Use Authorization (EUA) for Molecular-based Laboratory Developed Tests for Detection of Nucleic Acid from SARS-CoV-2 (Molecular LDT COVID-19 Authorized Test).
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration, Sanders, Christopher, Scherf, Uwe
Language: English
Type: Letter
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
Collection: Global Health Events web archive
Description: This one-page letter authorizes the emergency use of the Nationwide Children's Hospital SARS-CoV-2 Assay, which is eligible for authorization under the March 31, 2020, Emergency Use Authorization (EUA) for Molecular-based Laboratory Developed Tests for Detection of Nucleic Acid from SARS-CoV-2 (Molecular LDT COVID-19 Authorized Test).
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration, Leber, Amy L., Scherf, Uwe
Language: English
Type: Letter
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
Collection: Global Health Events web archive
Description: This one-page letter authorizes the emergency use of the AIT Laboratories SARS-CoV-2 Assay, which is eligible for authorization under the March 31, 2020, Emergency Use Authorization (EUA) for Molecular-based Laboratory Developed Tests for Detection of Nucleic Acid from SARS-CoV-2 (Molecular LDT COVID-19 Authorized Test).
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration, Grnager, John K., Scherf, Uwe
Language: English
Type: Letter
Collector: National Library of Medicine (U.S.)
Keyword: Basic Information, Biomedical Research
Collection: Global Health Events web archive
Description: This one-page letter authorizes the emergency use of the UDX SARS-CoV-2 Molecular Assay, which is eligible for authorization under the March 31, 2020, Emergency Use Authorization (EUA) for Molecular-based Laboratory Developed Tests for Detection of Nucleic Acid from SARS-CoV-2 (Molecular LDT COVID-19 Authorized Test).
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration, Tab, Sean, Scherf, Uwe
Language: English
Type: Letter
Collector: National Library of Medicine (U.S.)
Keyword: Basic Information, Biomedical Research
Collection: Global Health Events web archive
Description: This one-page letter authorizes the emergency use of the COVID-19 Key Assay, which is eligible for authorization under the March 31, 2020, Emergency Use Authorization (EUA) for Molecular-based Laboratory Developed Tests for Detection of Nucleic Acid from SARS-CoV-2 (Molecular LDT COVID-19 Authorized Test).
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration, Sanford, Nicholas, Scherf, Uwe
Language: English
Type: Letter
Collector: National Library of Medicine (U.S.)
Keyword: Basic Information, Biomedical Research
Collection: Global Health Events web archive
Description: This one-page letter authorizes the emergency use of the Diatherix SARS-CoV-2 PCR Test, which is eligible for authorization under the March 31, 2020, Emergency Use Authorization (EUA) for Molecular-based Laboratory Developed Tests for Detection of Nucleic Acid from SARS-CoV-2 (Molecular LDT COVID-19 Authorized Test).
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States. Food and Drug Administration, Scherf, Uwe
Language: English
Type: Letter
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
Collection: Global Health Events web archive
Description: This seven-page document, updated on April 24, 2020, details how the emergency use of face masks by the general public and healthcare workers, in accordance with Centers for Disease Control and Prevention recommendations, as personal protective equipment to help prevent spread of the virus during the COVID-19 pandemic meets the criteria for issuance of an Emergency Use Authorization.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration, Hinton, Denise M.
Language: English
Type: Letter
Collector: National Library of Medicine (U.S.)
Keyword: Basic Information, Biomedical Research
Collection: Global Health Events web archive
Description: This one-page letter authorizes the emergency use of the CDI Enhanced COVID-19 Test, which is eligible for authorization under the March 31, 2020, Emergency Use Authorization (EUA) for Molecular-based Laboratory Developed Tests for Detection of Nucleic Acid from SARS-CoV-2 (Molecular LDT COVID-19 Authorized Test).
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States. Food and Drug Administration, Scherf, Uwe
Language: English
Type: Letter
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
Collection: Global Health Events web archive
Description: This one-page letter authorizes the emergency use of the CirrusDx SARS-CoV-2 Assay, which is eligible for authorization under the March 31, 2020, Emergency Use Authorization (EUA) for Molecular-based Laboratory Developed Tests for Detection of Nucleic Acid from SARS-CoV-2 (Molecular LDT COVID-19 Authorized Test).
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States. Food and Drug Administration, Scherf, Uwe
Language: English
Type: Letter
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
Collection: Global Health Events web archive
Description: This one-page letter authorizes the emergency use of the Integrity Laboratories SARS-CoV-2 Assay, which is eligible for authorization under the March 31, 2020, Emergency Use Authorization (EUA) for Molecular-based Laboratory Developed Tests for Detection of Nucleic Acid from SARS-CoV-2 (Molecular LDT COVID-19 Authorized Test).
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States. Food and Drug Administration, Scherf, Uwe
Language: English
Type: Letter
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
Collection: Global Health Events web archive
Description: This one-page letter authorizes the emergency use of the UNC Health SARS-CoV-2 Real-Time RT-PCR Test, which is eligible for authorization under the March 31, 2020, Emergency Use Authorization (EUA) for Molecular-based Laboratory Developed Tests for Detection of Nucleic Acid from SARS-CoV-2 (Molecular LDT COVID-19 Authorized Test).
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States. Food and Drug Administration, Scherf, Uwe
Language: English
Type: Letter
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
Collection: Global Health Events web archive
Description: This one-page letter authorizes the emergency use of the SDI SARS-CoV-2 Assay, which is eligible for authorization under the March 31, 2020, Emergency Use Authorization (EUA) for Molecular-based Laboratory Developed Tests for Detection of Nucleic Acid from SARS-CoV-2 (Molecular LDT COVID-19 Authorized Test).
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States. Food and Drug Administration, Scherf, Uwe
Language: English
Type: Letter
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
Collection: Global Health Events web archive
Description: This one-page letter authorizes the emergency use of the Orig3n 2019 Novel Coronavirus (COVID-19) Test, which is eligible for authorization under the March 31, 2020, Emergency Use Authorization (EUA) for Molecular-based Laboratory Developed Tests for Detection of Nucleic Acid from SARS-CoV-2 (Molecular LDT COVID-19 Authorized Test).
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States. Food and Drug Administration, Scherf, Uwe
Language: English
Type: Letter
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
Collection: Global Health Events web archive
Description: The U.S. Food and Drug Administration (FDA) has issued this six-page Emergency Use Authorization (EUA) in response to concerns relating to insufficient supply and availability of face shields for use by healthcare personnel as personal protective equipment (PPE) in healthcare settings in accordance with Centers for Disease Control and Prevention recommendations to cover the front and sides of the face and provide barrier protection during the coronavirus disease 2019 (COVID-19) pandemic.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States. Food and Drug Administration, Hinton, Denise M.
Language: English
Type: Letter
Collector: National Library of Medicine (U.S.)
Keyword: Prevention and Control/Risk Management, Health Workforce
Collection: Global Health Events web archive
Description: This one-page document authorizes the emergency use of the Stanford SARS-CoV-2 PCR Assay, which is eligible for authorization under the March 31, 2020, Emergency Use Authorization (EUA) for Molecular-based Laboratory Developed Tests for Detection of Nucleic Acid from SARS-CoV-2 (Molecular LDT COVID-19 Authorized Test).
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration, Kong, Christina S., Hinton, Denise M.
Language: English
Type: Letter
Collector: National Library of Medicine (U.S.)
Keyword: Basic Information, Biomedical Research
Collection: Global Health Events web archive
Description: This one-page document authorizes the emergency use of the Viracor SARS-CoV-2 Assay, which is eligible for authorization under the March 31, 2020, Emergency Use Authorization (EUA) for Molecular-based Laboratory Developed Tests for Detection of Nucleic Acid from SARS-CoV-2 (Molecular LDT COVID-19 Authorized Test).
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States. Food and Drug Administration, Scherf, Uwe
Language: English
Type: Letter
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
Collection: Global Health Events web archive
Description: This nine-page letter, revised on June 6, 2020, updates the April 3, 2020, Emergency Use Authorization for certain product classifications for imported disposable filtering facepiece respirators that are manufactured in China and not approved by the Centers for Disease Control and Prevention's National Institute of Occupational Safety and Health (NIOSH). The Scope of Authorization was revised such that authorized respirators listed in Appendix A will no longer be authorized if decontaminated.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration, Hinton, Denise M.
Language: English
Type: Letter
Collector: National Library of Medicine (U.S.)
Keyword: Basic Information, Biomedical Research
Collection: Global Health Events web archive
Description: This two-page letter authorizes the emergency use of the Northwestern Diagnostic Molecular Laboratory SARS-Cov-2 Assay, which is eligible for authorization under the March 31, 2020, Emergency Use Authorization (EUA) for Molecular-based Laboratory Developed Tests for Detection of Nucleic Acid from SARS-CoV-2 (Molecular LDT COVID-19 Authorized Test).
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States. Food and Drug Administration, Scherf, Uwe
Language: English
Type: Letter
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
Collection: Global Health Events web archive
Description: This one-page letter authorizes the emergency use of the Infectious Disease Diagnostics Laboratory, Department of Pathology and Laboratory Medicine at the Children's Hospital of Philadelphia SARS-CoV-2 PCR Test, which is eligible for authorization under the March 31, 2020, Emergency Use Authorization (EUA) for Molecular-based Laboratory Developed Tests for Detection of Nucleic Acid from SARS-CoV-2 (Molecular LDT COVID-19 Authorized Test).
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States. Food and Drug Administration, Scherf, Uwe
Language: English
Type: Letter
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
Collection: Global Health Events web archive
Description: This one-page letter authorizes the emergency use of the Yale New Haven Hospital SARS-CoV-2 PCR Test, which is eligible for authorization under the March 31, 2020, Emergency Use Authorization (EUA) for Molecular-based Laboratory Developed Tests for Detection of Nucleic Acid from SARS-CoV-2 (Molecular LDT COVID-19 Authorized Test).
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States. Food and Drug Administration, Scherf, Uwe
Language: English
Type: Letter
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
Collection: Global Health Events web archive
Description: This 10-page Letter of Authorization was updated on June 6, 2020, with five revisions regarding the emergency use of the authorized respirators, as described in the Scope of Authorization (Section II) and pursuant to the Conditions of Authorization (Section IV) of this letter for use in healthcare settings by healthcare providers when used in accordance with CDC recommendations to prevent wearer exposure to pathogenic biological airborne particulates during filtering facepiece respirator shortages resulting from the COVID-19 outbreak.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration, Hinton, Denise M.
Language: English
Type: Letter
Collector: National Library of Medicine (U.S.)
Keyword: Basic Information, Biomedical Research
Collection: Global Health Events web archive
Description: This nine-page letter, reissued multiple times, authorizes certain National Institute for Occupational Safety and Health (NIOSH)-approved respirators not currently regulated by the Food and Drug Administration (FDA) to be used in a health care setting by health care personnel during the coronavirus (COVID-19) outbreak, thereby maximizing the number of respirators available to meet the needs of the U.S. health care system. When properly fitted, respirators, such as N95s, can filter more airborne particles than face masks, which is important during an outbreak of a respiratory disease like COVID-19.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States. Food and Drug Administration, Hinton, Denise, M.
Language: English
Type: Letter
Collector: National Library of Medicine (U.S.)
Collection: Global Health Events web archive
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Group: Coronavirus disease (COVID-19) outbreak
Creator: American Laryngological, Rhinological, and Otological Society, Chiu, Alexander G.
Language: English
Type: Letter
Geographic Location: Kansas
Collector: National Library of Medicine (U.S.)
Keyword: Psychological Preparedness and Responses, Personal Narratives, Health Workforce
Collection: Global Health Events web archive
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Group: Coronavirus disease (COVID-19) outbreak
Creator: Disabled Veterans National Foundation, VanFonda, Joseph
Language: English
Type: Letter
Collector: National Library of Medicine (U.S.)
Keyword: Vulnerable Populations, Combat Veterans
Collection: Global Health Events web archive
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Group: Coronavirus disease (COVID-19) outbreak
Creator: Disabled Veterans National Foundation, VanFonda, Joseph
Language: English
Type: Letter
Collector: National Library of Medicine (U.S.)
Keyword: Vulnerable Populations, Combat Veterans
Collection: Global Health Events web archive
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Group: Coronavirus disease (COVID-19) outbreak
Creator: Newspapers of New England, Wyzik, Phil
Language: English
Type: Letter
Collector: National Library of Medicine (U.S.)
Keyword: Prevention and Control/Risk Management, Social Dimensions
Collection: Global Health Events web archive
Description: This three-page memorandum provides guidance to surveyors in regard to the authorization for emergency use of the Centers for Disease Control and Prevention (CDC)'s 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel assay. Upon receipt of the CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel assay and corresponding manufacturer's instructions (MI), CDC-qualified laboratories will verify assay performance specifications in their laboratory per the manufacturer's instructions.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: Centers for Medicare & Medicaid Services (U.S.)
Language: English
Type: Letter
Collector: National Library of Medicine (U.S.)
Keyword: Health Facilities, Tracking the Disease
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