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Sites and collections from this organization are listed below. Narrow your results at left, or enter a search query below to find a collection, site, specific URL or to search the text of archived webpages.
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Collection: Global Health Events web archive
Description: This project aims to harmonize a list of COVID-19 data elements with several Common Data Models (CDMs) and open standards. This web page provides information about the project and a mapping table, which is a continuously evolving document intended to serve as a resource.
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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.)
Keyword: Tracking the Disease
Collection: Global Health Events web archive
Description: The FDA is issuing this 14-page guidance to provide sponsors and investigators with considerations for approaches on how common COVID-19-related symptoms can be measured and analyzed in clinical trials evaluating drugs or biological products for the prevention or treatment of COVID-19 in outpatient adult and adolescent subjects.
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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.)
Keyword: Tracking the Disease, Vulnerable Populations, Children
Collection: Global Health Events web archive
Description: This 24-page guidance was issued to assist sponsors in the clinical development and licensure of vaccines for the prevention of COVID-19, and describes the FDA's current recommendations regarding the data needed to facilitate clinical development and licensure of vaccines to prevent COVID-19.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration , Center for Biologics Evaluation and Research (U.S.)
Language: English
Type: Publication
Collector: National Library of Medicine (U.S.)
Keyword: Vaccines
Collection: Global Health Events web archive
Description: The Food and Drug Administration (FDA) has issued this 18-page guidance to provide sponsors of requests for Emergency Use Authorization (EUA) for COVID-19 vaccines with recommendations regarding the data and information needed to support the issuance of an EUA for an investigational vaccine to prevent COVID-19 for the duration of the COVID-19 public health emergency.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration , Center for Biologics Evaluation and Research (U.S.)
Language: English
Type: Publication
Collector: National Library of Medicine (U.S.)
Keyword: Vaccines, Basic Information
Collection: Global Health Events web archive
Description: This 14-page guidance provides a policy to help expand the availability of general use face masks for the general public and particulate filtering facepiece respirators (including N95 respirators) for healthcare professionals during the COVID-19 pandemic.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration , National Center for Devices and Radiological Health (U.S.)
Language: English
Type: Publication
Collector: National Library of Medicine (U.S.)
Keyword: Prevention and Control/Risk Management, Health Workforce
Collection: Global Health Events web archive
Description: This nine-page guidance was issued to provide a policy to help expand access to certain FDA-cleared molecular assays intended for detection and identification of influenza (flu) viruses, including those molecular influenza assays that also detect and identify respiratory syncytial viruses (RSV), during the influenza season and for the duration of the COVID-19 public health emergency.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration , Center for Devices and Radiological Health (U.S.), Office of Product Evaluation and Quality
Language: English
Type: Publication
Collector: National Library of Medicine (U.S.)
Keyword: Biomedical Research, Basic Information
Collection: Global Health Events web archive
Description: The FDA is issuing this 12-page guidance to help facilitate the availability of devices for use in transporting certain clinical specimens, including transport media that can be used to transport certain clinical specimens for use with molecular Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR) Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) assays or antigen-detection diagnostic SARS-CoV-2 assays for the duration of the COVID-19 public health emergency.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration , National Center for Devices and Radiological Health (U.S.)
Language: English
Type: Publication
Collector: National Library of Medicine (U.S.)
Keyword: Basic Information
Collection: Global Health Events web archive
Description: The Food and Drug Administration (FDA) has issued this 35-page guidance, updated on September 21, 2020, to provide general considerations to assist sponsors in assuring the safety of trial participants in the conduct of clinical trials of medical products, maintaining compliance with good clinical practice (GCP), and minimizing risks to trial integrity during the COVID-19 (coronavirus) pandemic.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration , Center for Biologics Evaluation and Research (U.S.), Center for Devices and Radiological Health, Center for Drug Evaluation and Research
Language: English
Type: Publication
Collector: National Library of Medicine (U.S.)
Keyword: Health Workforce
Collection: Global Health Events web archive
Description: This eight-page guidance was issued to provide recommendations regarding the key factors and procedures that institutional review boards (IRBs) should consider when reviewing expanded access submissions for individual patient access to investigational drugs for treating COVID-19.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration , Center for Drug Evaluation and Research (U.S.)
Language: English
Type: Publication
Collector: National Library of Medicine (U.S.)
Keyword: Basic Information
Collection: Global Health Events web archive
Description: This 17-page guidance, updated on September 2, 2020, provides recommendations to healthcare providers and investigators on the administration and study of investigational convalescent plasma collected from individuals who have recovered from COVID-19 (COVID-19 convalescent plasma) during the public health emergency. The guidance also provides recommendations to blood establishments on the collection of COVID-19 convalescent plasma.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration , Center for Biologics Evaluation and Research (U.S.)
Language: English
Type: Publication
Collector: National Library of Medicine (U.S.)
Keyword: Basic Information
Collection: Global Health Events web archive
Description: This 20-page guidance, updated on May 11, 2020, provides a policy to help accelerate the availability of novel coronavirus (COVID-19) tests developed by laboratories and commercial manufacturers for the duration of the public health emergency.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration , National Center for Devices and Radiological Health (U.S.)
Language: English
Type: Publication
Collector: National Library of Medicine (U.S.)
Keyword: Health Policy Advocacy, Basic Information
Page 1 of 1 (11 Total Results)
