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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: 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
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