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Collection: Global Health Events web archive
Description: The purpose of this 15-page review is for the Division of Pharmacovigilance II to provide the Division of Antiviral Drug Products a high-level overview of the postmarketing safety data related to the use of hydroxychloroquine and chloroquine in the setting of coronavirus disease 2019 (COVID-19). It identifies two emerging safety signals.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States. Department of Health and Human Services, Public Health Service, United States Food and Drug Administration , 80126147, Center for Drug Evaluation and Research, Office of Surveillance and Epidemiology
Language: English
Type: Report
Collector: National Library of Medicine (U.S.)
Keyword: Basic Information
Collection: Global Health Events web archive
Description: This 38-page document is a briefing paper for a meeting to be held on October 22, 2020, to discuss studies that should be conducted, pre- and/or post-licensure, to evaluate the safety and efficacy of COVID-19 vaccine candidates, including in special populations (e.g., pediatric populations and pregnant women), and to further evaluate the immunogenicity and duration of effectiveness of these vaccines. The committee will also be asked to discuss the need for post-marketing safety studies following approval of a Biologics License Application (BLA) for a COVID-19 vaccine.
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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, Basic Information
Collection: Global Health Events web archive
Description: This five-page document describes four lines of evidence that continue to support the emergency use of COVID-19 Convalescent Plasma at this time, one month after initial issuance of the Emergency Use Authorization: 1) historical data regarding prior experience with the use of convalescent plasma in other outbreak settings; 2) data from animal studies; 3) data that continues to emerge in the published literature from clinical studies performed during the current outbreak; and 4) results obtained from a large expanded access treatment protocol (National Expanded Program).
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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: Basic Information, Biomedical Research
Collection: Global Health Events web archive
Description: This web page, updated on July 2, 2020, provides information about routine screening measures that are already in place for evaluating clinical evidence of infection in human cell, tissue, or cellular or tissue-based product (HCT/P) donors. To date, there have been no reported cases of transmission of COVID-19 via these products. FDA does not recommend using laboratory tests to screen asymptomatic HCT/P donors.
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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
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