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Collection: Global Health Events web archive
Description: Page on the US Food and Drug Administration (USDA) website featuring the most recent updates on the Ebola response at the Food and Drug Administration (FDA) in French. The FDA is working to expedite the development and availability of medical products, including treatments, vaccines, diagnostic tests, and personal protective equipment, that may help to end the Ebola epidemic in West Africa.
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Group: Ebola Outbreak 2014
Creator: United States. Food and Drug Administration
Language: English
Type: Website
Collector: National Library of Medicine (U.S.)
Keyword: Prevention and Control/Risk Management, Patient Treatment and Experience, Vaccines
Collection: Women's Health web archive
Description: Website from U.S. Food and Drug Administration regarding women in clinical trials.
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Creator: United States. Food and Drug Administration
Language: English
Type: Website
Rights: The National Library of Medicine believes this item to be in the public domain.
Collector: National Library of Medicine (U.S.)
Keyword: Medical Research, Gender Disparities
Collection: Women's Health web archive
Description: Website from U.S. Food and Drug Administration regarding women and depression. Information includes signs of depression, treatment, pregnancy, and other resources.
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Creator: United States. Food and Drug Administration
Language: English
Type: Website
Rights: The National Library of Medicine believes this item to be in the public domain.
Collector: National Library of Medicine (U.S.)
Keyword: Medical Research
Collection: Global Health Events web archive
Description: Website from U.S. Food and Drug Administration regarding the use of Ivermectin to treat COVID-19
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States. Food and Drug Administration
Language: English
Type: Website
Collector: National Library of Medicine (U.S.)
Keyword: Patient Treatment and Experience, Biomedical Research
Collection: Global Health Events web archive
Description: This one-hour webinar was held for device manufacturers and industry to discuss and answer questions on the recently issued, immediately in effect guidances on enforcement policy for personal protective equipment (PPE) during COVID-19. The two guidances discussed were Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency (Revised); and Enforcement Policy for Gowns, Other Apparel, and Gloves During the Coronavirus Disease (COVID-19) Public Health Emergency.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States. Food and Drug Administration
Language: English
Type: Website
Collector: National Library of Medicine (U.S.)
Collection: Global Health Events web archive
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States. Food and Drug Administration , Califf, Robert M., Marks, Peter
Language: English
Type: Video recording
Social Media Host: YouTube (Firm)
Collector: National Library of Medicine (U.S.)
Keyword: Vaccines
Collection: Global Health Events web archive
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States. Food and Drug Administration
Language: English
Type: Report
Collector: National Library of Medicine (U.S.)
Keyword: Vaccines
Collection: Global Health Events web archive
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States. Food and Drug Administration
Language: English
Type: Publication
Collector: National Library of Medicine (U.S.)
Collection: Global Health Events web archive
Description: Website for Vaccine Adverse Event Reporting System regarding reactions to the vaccine, links to resources, ways to reports, submitting follow-up information, helpful links, learning tools and vaccine safety information
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States. Department of Health and Human Services, Centers for Disease Control and Prevention (U.S.), United States. Food and Drug Administration
Language: English
Type: Website
Collector: National Library of Medicine (U.S.)
Keyword: Prevention and Control/Risk Management, Vaccines, Patient Treatment and Experience
Collection: Global Health Events web archive
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States. Food and Drug Administration
Language: English
Type: Social media
Social Media Host: Twitter (Firm)
Collector: National Library of Medicine (U.S.)
Keyword: Biomedical Research, Vaccines
Collection: Global Health Events web archive
Description: Twitter account page for the Food and Drug Administration (FDA).
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Group: Global Health Organizations
Creator: United States. Food and Drug Administration
Language: English
Type: Social media
Social Media Host: Twitter (Firm)
Collector: National Library of Medicine (U.S.)
Keyword: Prevention and Control/Risk Management, Legislation and Jurisprudence
Collection: Global Health Events web archive
Description: Website from the Food and Drug Administration, "Tips on Good Nutrition and Using the Updated Nutrition Facts Label During the Coronavirus Pandemic", with guidance and resources.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States. Food and Drug Administration
Language: English
Type: Website
Collector: National Library of Medicine (U.S.)
Keyword: Basic Information
Collection: Opioid Epidemic web archive
Description: Page on the United State Food and Drug Administration (FDA) Website displaying a timeline of the agency's activities and significant events addressing opioid misuse and abuse from 1911 through 2018. The site features a summary timeline in addition to the full version.
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Creator: United States. Food and Drug Administration
Language: English
Type: Website
Collector: National Library of Medicine (U.S.)
Collection: Opioid Epidemic web archive
Description: Page on the Food and Drug Administration's (FDA) Website that features the transcription of Department of Health and Human Services (HHS) witnesses' testimony given before the Senate Health, Education, Labor and Pensions Committee on October 5, 2017 regarding the federal response to the Opioid Epidemic.
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Creator: United States. Food and Drug Administration
Language: English
Type: Report
Collector: National Library of Medicine (U.S.)
Collection: Global Health Events web archive
Description: The DPP COVID-19 IgM/IgG System from ChemBio was tested at the Frederick National Laboratory for Cancer Research (FNLCR), a Federally Funded Research and Development Center (FFRDC) sponsored by the National Cancer Institute (NCI). This 11-page report evaluates the test. Tests were from lot number 204IG001Z. The DPP COVID-19 IgM/IgG System is intended to qualitatively detect IgM and IgG separately.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States. Food and Drug Administration
Language: English
Type: Report
Collector: National Library of Medicine (U.S.)
Keyword: Biomedical Research
Collection: Global Health Events web archive
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States. Food and Drug Administration
Language: English
Type: Website
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease, Variants, Basic Information, Omicron
Collection: Women's Health web archive
Description: Website from U.S. Food and Drug Administration regarding regulations, guidance, and reports related to Women's Health.
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Creator: United States. Food and Drug Administration
Language: English
Type: Website
Rights: The National Library of Medicine believes this item to be in the public domain.
Collector: National Library of Medicine (U.S.)
Keyword: Medical Research, Gender Disparities
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
Description: Website from U.S. Food and Drug Administration, up to date press announcements
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States. Food and Drug Administration
Language: English
Type: Website
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease, Prevention and Control/Risk Management, Biomedical Research, Patient Treatment and Experience
Collection: Global Health Events web archive
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States. Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Basic Information, Vaccines, Patient Treatment and Experience, Prevention and Control/Risk Management
Collection: Opioid Epidemic web archive
Description: PowerPoint Presentation titled, "Overdose Prevention and Response Training: Lessons from Rhode Island," by Traci Green of the Boston Medical Center Injury Prevention Center hosted by the U.S. Food and Drug Administration (FDA). The Presentation states that pharmacists and prescribers need to undergo basic training in recognizing overdoses, knowing state laws, and in providing counseling to patients.
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Creator: United States. Food and Drug Administration , Green, Traci G.
Language: English
Type: Website
Collector: National Library of Medicine (U.S.)
Collection: Opioid Epidemic web archive
Description: Page on the Food and Drug Administration's (FDA) Website dedicated to opioid medications.
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Creator: United States. Food and Drug Administration
Language: English
Type: Website
Collector: National Library of Medicine (U.S.)
Collection: Global Health Events web archive
Description: Page on the US Food and Drug Administration (USDA) website featuring the most recent information and updates on the Novel coronavirus (COVID-19).
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States. Food and Drug Administration
Language: English
Type: Website
Collector: National Library of Medicine (U.S.)
Keyword: Prevention and Control/Risk Management, Legislation and Jurisprudence
Collection: Global Health Events web archive
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States. Food and Drug Administration
Language: English
Type: Fact sheet
Geographic Location: New York
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
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
Description: Website from U.S. Food and Drug Administration regarding multilingual COVID-19 Resources and COVID-19 Vaccine myths with links for simplified Chinese, Korean, Tagalog, Vietnamese, Portuguese, Hmong, and Somali
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States. Food and Drug Administration
Language: English
Type: Website
Collector: National Library of Medicine (U.S.)
Collection: Avian Influenza A (H7N9) Virus web archive
Description: List of authorized medical devices for use in the event of an Avian Flu outbreak.
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Creator: United States. Food and Drug Administration
Language: English
Type: Website
Collector: National Library of Medicine (U.S)
Collection: Global Health Events web archive
Description: Website from the U.S. Food and Drug Administration regarding medical devise shortages during COVID-19 public health emergency.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States. Food and Drug Administration
Language: English
Type: Website
Collector: National Library of Medicine (U.S.)
Keyword: Adapting Technology, 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 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 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 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 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 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 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 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: 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 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
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States. Food and Drug Administration
Language: English
Type: Video recording
Social Media Host: YouTube (Firm)
Collector: National Library of Medicine (U.S.)
Keyword: Vaccines, Tracking the Disease
Collection: Global Health Events web archive
Description: This web page is intended to address questions related to the design, evaluation, labeling, and marketing of hospital beds, stretchers, and mattresses during the COVID-19 public health emergency.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States. Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Health Facilities
Collection: HIV/AIDS web archive
Description: Page on the U.S. Food and Drug Administration (FDA) Website dedicated to HIV/AIDS. The page explains the FDA's role in fighting HIV/AIDS, which includes preventative services such as monitoring blood supplies, ensuring quality of barrier products, aiding in the development of therapeutic medicines and vaccines for HIV/AIDS and preventative microbicides and ensuring proper sterilization and disinfection in reprocessing medical devices, as well as testing, research, field inspections and opening up access to drugs available abroad.
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Creator: United States. Food and Drug Administration
Language: English
Type: Website
Rights: The National Library of Medicine believes this item to be in the public domain.
Collector: National Library of Medicine (U.S.)
Collection: Global Health Events web archive
Description: Website from the Food and Drug Administration, "Helpful Questions and Answers about Coronavirus (COVID-19) and Your Pets", with frequently asked questions.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States. Food and Drug Administration
Language: English
Type: Website
Collector: National Library of Medicine (U.S.)
Keyword: Basic Information
Collection: Global Health Events web archive
Description: This three-page fact provides answers to frequently asked questions about the revocation of the Emergency Use Authorization for hydroxychloroquine sulfate and chloroquine phosphate to treat COVID-19. The Food and Drug Administration has determined that these drugs are unlikely to be effective in treating COVID-19 for the authorized uses in the EUA.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States. Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Basic Information
Collection: Women's Health web archive
Description: Website from U.S. Food and Drug Administration regarding women's health. Links to free publications, health topics, news and blogs, public meetings, workshops and webinars.
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Creator: United States. Food and Drug Administration
Language: English
Type: Website
Rights: The National Library of Medicine believes this item to be in the public domain.
Collector: National Library of Medicine (U.S.)
Keyword: Support for Mental Health, Depression
Collection: Global Health Events web archive
Description: Website from the Food and Drug Administration, "Food Safety and Availability During the Coronavirus Pandemic", with frequently asked questions.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States. Food and Drug Administration
Language: English
Type: Website
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: United States. Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Collection: Global Health Events web archive
Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the qSARS-CoV-2 lgG/lgM Rapid Test, which received an Emergency Use Authorization from the Food and Drug Administration on April 1, 2020. The qSARS-CoV-2 lgG/lgM Rapid Test is authorized for use on serum, plasma, or venipuncture whole blood specimens from people suspected of Coronavirus Disease 2019 (COVID-19) by their healthcare provider.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States. Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
Collection: Global Health Events web archive
Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the iAMP COVID-19 Detection Kit, which received an Emergency Use Authorization from the Food and Drug Administration on April 10, 2020. The iAMP COVID-19 Detection Kit is authorized for use on respiratory specimens collected 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
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
Collection: Global Health Events web archive
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States. Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
Collection: Global Health Events web archive
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States. Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease, Basic Information
Collection: Global Health Events web archive
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States. Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
Collection: Global Health Events web archive
Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack test, which received an Emergency Use Authorization from the Food and Drug Administration on April 14, 2020. The VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack test is authorized for use on serum and EDTA plasma specimens from individuals suspected of coronavirus disease 2019 (COVID-19) by their healthcare provider.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States. Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
Collection: Global Health Events web archive
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States. Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Prevention and Control/Risk Management, Tracking the Disease
Collection: Global Health Events web archive
Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the Smart Detect SARS-CoV-2 rRT-PCR Kit, which received an Emergency Use Authorization from the Food and Drug Administration on April 7, 2020. The Smart Detect SARS-CoV-2 rRT-PCR Kit is authorized for use on using respiratory specimens collected 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
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
Collection: Global Health Events web archive
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States. Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
Collection: Global Health Events web archive
Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the ScienCell SARS-CoV-2 Coronavirus Real-time RT-PCR (RT-qPCR) Detection Kit, which received an Emergency Use Authorization from the Food and Drug Administration on April 3, 2020. The ScienCell SARS-CoV-2 Coronavirus Real-time RT-PCR (RT-qPCR) Detection Kit is authorized for use on using respiratory specimens collected 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
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
Collection: Global Health Events web archive
Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the STANDARD M nCoV Real-Time Detection kit, which received an Emergency Use Authorization from the Food and Drug Administration on April 23, 2020. The STANDARD M nCoV Real-Time Detection kit is authorized for use on respiratory specimens collected from individuals who are 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
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
Collection: Global Health Events web archive
Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the SARS-CoV-2 Fluorescent PCR Kit, which received an Emergency Use Authorization from the Food and Drug Administration on April 14, 2020. The SARS-CoV-2 Fluorescent PCR Kit is authorized for use on using respiratory specimens collected from individuals suspected of COVID-19 by their healthcare providers.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States. Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
Collection: Global Health Events web archive
Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the RealStar® SARS-CoV-2 RT-PCR Kit U.S., which received an Emergency Use Authorization from the Food and Drug Administration on April 22, 2020. The RealStar® SARS-CoV-2 RT-PCR Kit U.S. is authorized for use on respiratory specimens collected from individuals who are 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
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
Collection: Global Health Events web archive
Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the QuantiVirus SARS-CoV-2 Test kit, which received an Emergency Use Authorization from the Food and Drug Administration on April 8, 2020. The QuantiVirus SARS-CoV-2 Test kit is authorized for use on using respiratory specimens collected 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
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
Collection: Global Health Events web archive
Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the QIAstat-Dx Respiratory SARS-CoV-2 Panel, which received an Emergency Use Authorization from the Food and Drug Administration on March 30, 2020. The QIAstat-Dx Respiratory SARS-CoV-2 Panel is authorized for use on respiratory specimens collected from patients 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
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
Collection: Global Health Events web archive
Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the PhoenixDx® 2019-CoV, which received an Emergency Use Authorization from the Food and Drug Administration on April 20, 2020. The PhoenixDx® 2019-CoV is authorized for use on respiratory specimens collected 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
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
Collection: Global Health Events web archive
Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the PerkinElmer New Coronavirus Nucleic Acid Detection Kit, which received an Emergency Use Authorization from the Food and Drug Administration on March 24, 2020. The PerkinElmer New Coronavirus Nucleic Acid Detection Kit is authorized for use on using respiratory specimens collected 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
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
Collection: Global Health Events web archive
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States. Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
Collection: Global Health Events web archive
Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the NxTAG CoV Extended Panel Assay, which received an Emergency Use Authorization from the Food and Drug Administration on March 27, 2020. The NxTAG CoV Extended Panel Assay is authorized for use on using respiratory specimens collected 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
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
Collection: Global Health Events web archive
Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the NeuMoDx SARS-CoV-2 Assay, which received an Emergency Use Authorization from the Food and Drug Administration on March 30, 2020. The NeuMoDx SARS-CoV-2 Assay is authorized for use on respiratory specimens collected 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
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Collection: Global Health Events web archive
Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of a Molecular Laboratory Developed Test (LDT) COVID-19 Authorized Test (Molecular LDT COVID-19 Authorized Test) that has been issued an Emergency Use Authorization (EUA) by the FDA. The Molecular LDT COVID-19 Authorized Test is authorized for use on respiratory specimens collected 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
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
Collection: Global Health Events web archive
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States. Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
Collection: Global Health Events web archive
Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the Logix Smart Coronavirus Disease 2019 (COVID-19) kit, which received an Emergency Use Authorization from the Food and Drug Administration on April 3, 2020. The Logix Smart COVID-19 kit is authorized for use on using respiratory specimens collected from individuals who are 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
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
Collection: Global Health Events web archive
Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the ID NOW COVID-19, which received an Emergency Use Authorization from the Food and Drug Administration on March 27, 2020. The ID NOW COVID-19 is authorized for use on respiratory specimens collected from individuals who are 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
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
Collection: Global Health Events web archive
Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the Gnomegen COVID-19 RT-Digital PCR Detection Kit, which received an Emergency Use Authorization from the Food and Drug Administration on April 6, 2020. The Gnomegen COVID-19 RT-Digital PCR Detection Kit is authorized for use on respiratory specimens collected from individuals who are 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
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
Collection: Global Health Events web archive
Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the GeneFinder COVID-19 Plus RealAmp Kit, which received an Emergency Use Authorization from the Food and Drug Administration on April 19, 2020. The GeneFinder COVID-19 Plus RealAmp Kit is authorized for use on respiratory specimens collected 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
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
Collection: Global Health Events web archive
Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the GSTM COVID-19 RT-PCR KIT, which received an Emergency Use Authorization from the Food and Drug Administration on April 16, 2020. The GSTM COVID-19 RT-PCR KIT is authorized for use on using respiratory specimens collected 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
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
Collection: Global Health Events web archive
Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the Fosun COVID-19 RT-PCR Detection Kit, which received an Emergency Use Authorization from the Food and Drug Administration on April 17, 2020. The Fosun COVID-19 RT-PCR Detection Kit is authorized for use on respiratory specimens collected 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
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
Collection: Global Health Events web archive
Description: This two-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the Lungpacer Diaphragm Pacing Therapy System during the COVID-19 pandemic, which received an Emergency Use Authorization from the Food and Drug Administration on April 3, 2020. It is for use with patients with COVID-19 and other illnesses or conditions that require mechanical ventilation, who are not spontaneously breathing, and are expected to require prolonged ventilation.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States. Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Patient Treatment and Experience
Collection: Global Health Events web archive
Description: This two-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the oXiris Set device for the reduction of pro-inflammatory mediators, which received an Emergency Use Authorization from the Food and Drug Administration on April 22, 2020. The oXiris Set device is authorized for emergency use to treat patients 18 years of age or older with confirmed COVID-19 admitted to the intensive care unit (ICU) with confirmed or imminent respiratory failure in need of blood purification, including use in continuous renal replacement therapy.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States. Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Patient Treatment and Experience
Collection: Global Health Events web archive
Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the TransAeris® Diaphragm Pacing System during the COVID-19 pandemic, which received an Emergency Use Authorization from the Food and Drug Administration on April 13, 2020. The TransAeris® Diaphragm Pacing System is authorized for use in healthcare settings to assist in weaning patients determined by their healthcare provider to be at high risk of weaning failure off ventilators, for no more than 30 days.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States. Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Patient Treatment and Experience
Collection: Global Health Events web archive
Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the CytoSorb device for the reduction of pro-inflammatory cytokine levels, which received an Emergency Use Authorization from the Food and Drug Administration on April 10, 2020. The CytoSorb device is authorized for emergency use to treat patients 18 years of age or older with confirmed COVID-19 admitted to the intensive care unit (ICU) with confirmed or imminent respiratory failure.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States. Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Patient Treatment and Experience
Collection: Global Health Events web archive
Description: The Food and Drug Administration issued an Emergency Use Authorization (EUA) for the emergency use of the Perfusor Space Syringe Infusion Pump System, Infusomat Space Volumetric Infusion Pump System, and Outlook ES (Braun Space and Outlook Pumps) for use in the tracheal delivery of continuous nebulized medications into a nebulizer to treat patients of all ages with or suspected of having COVID-19 and decrease the exposure of healthcare providers to such patients during the COVID-19 pandemic. The EUA was also issued for ground medical transport use of the Infusomat Space Volumetric Infusion Pump System.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States. Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Collection: Global Health Events web archive
Description: This two-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of ventilators, anesthesia gas machines modified for use as ventilators, and positive pressure breathing devices modified for use as ventilators (collectively referred to as "ventilators"), ventilator tubing connectors, and ventilator accessories that are authorized for emergency use in healthcare settings for treatment of patients during the COVID-19 pandemic by their healthcare providers.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States. Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Health Facilities, Patient Treatment and Experience
Collection: Global Health Events web archive
Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the Spectra Optia Apheresis System with the Depuro D2000 Adsorption Cartridge for the reduction of pro-inflammatory cytokine levels, which received an Emergency Use Authorization from the Food and Drug Administration on April 9, 2020. The Spectra Optia Apheresis System with the Depuro D2000 Adsorption Cartridge is authorized for emergency use to treat patients 18 years of age or older with confirmed COVID-19 admitted to the intensive care unit (ICU) with confirmed or imminent respiratory failure.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States. Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Patient Treatment and Experience
Collection: Global Health Events web archive
Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the Seraph 100 Microbind Affinity Blood Filter device for the reduction of pathogens and inflammatory mediators. The Seraph 100 Microbind Affinity Blood Filter device was authorized for emergency use by the Food and Drug Administration on April 17, 2020, to treat patients 18 years of age or older with confirmed COVID-19 admitted to the intensive care unit (ICU) with confirmed or imminent respiratory failure.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States. Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Adapting Technology, Patient Treatment and Experience, Prevention and Control/Risk Management
Collection: Global Health Events web archive
Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the Philips IntelliVue Patient Monitors MX750 and MX850; Philips IntelliVue 4-Slot Module Rack FMX-4; and Philips IntelliVue Active Displays AD75 and AD85, which received an Emergency Use Authorization from the Food and Drug Administration on April 22, 2020. These devices are authorized for emergency use by healthcare professionals in the hospital environment for the monitoring of patients having or suspected of having COVID-19, to reduce healthcare provider exposure to COVID-19.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States. Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Patient Treatment and Experience
Collection: Global Health Events web archive
Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the Curative-Korva SARS-Cov-2 Assay, which received an Emergency Use Authorization from the Food and Drug Administration on April 16, 2020. The Curative-Korva SARS-Cov-2 Assay is authorized for use on using respiratory specimens collected 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
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
Collection: Global Health Events web archive
Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the COVID-19 ELISA IgG Antibody Test, which received an Emergency Use Authorization from the Food and Drug Administration on April 15, 2020. The COVID-19 ELISA IgG Antibody Test is authorized for use on serum or plasma specimens from individuals suspected of prior infection with the virus that causes coronavirus disease 2019 (COVID-19) by their healthcare provider.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States. Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
Collection: Global Health Events web archive
Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the COV-19 IDx assay, which received an Emergency Use Authorization from the Food and Drug Administration on April 1, 2020. The COV-19 IDx assay is authorized for use on using respiratory specimens collected 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
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
Collection: Global Health Events web archive
Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the BioGX SARS-CoV-2 Reagents for BD MAX System, which received an Emergency Use Authorization from the Food and Drug Administration on April 2, 2020. The BioGX SARS-CoV-2 Reagents for BD MAX System is authorized for use on using respiratory specimens collected 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
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
Collection: Global Health Events web archive
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States. Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
Collection: Global Health Events web archive
Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the BD SARS-CoV-2 Reagents for BD MAX System, which received an Emergency Use Authorization from the Food and Drug Administration on April 8, 2020. The BD SARS-CoV-2 Reagents for BD MAX System is authorized for use on using respiratory specimens collected 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
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
Collection: Global Health Events web archive
Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the AvellinoCoV2, which received an Emergency Use Authorization from the Food and Drug Administration on March 25, 2020. The AvellinoCoV2 is authorized for use on using respiratory specimens collected 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
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
Collection: Global Health Events web archive
Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the Allplex 2019-nCoV Assay, which received an Emergency Use Authorization from the Food and Drug Administration on April 21, 2020. The Allplex 2019-nCoV Assay is authorized for use on respiratory specimens collected from individuals who are 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
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
Collection: Global Health Events web archive
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States. Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
Collection: Global Health Events web archive
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States. Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
Collection: Global Health Events web archive
Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the ARIES® SARS-CoV-2 Assay, which received an Emergency Use Authorization from the Food and Drug Administration on April 3, 2020. The ARIES® SARS-CoV-2 Assay is authorized for use on respiratory 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
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
Collection: Global Health Events web archive
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States. Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Collection: Global Health Events web archive
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States. Food and Drug Administration