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National Library of Medicine

Archive-It Partner Since: Mar, 2009

Organization Type: National Institutions

Organization URL: http://www.nlm.nih.gov/   

Description:

The National Library of Medicine (NLM), the world's largest medical library and a component of the National Institutes of Health, collects, preserves, and makes available to the public information about health, medicine, and the biomedical sciences. To continue fulfilling this mission, NLM is collecting and archiving related Web content, which also serves to document the histories of health and medicine. For questions about our web archiving program contact us at nlmwebcollecting@nlm.nih.gov.

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Title: All adverse events in the setting of COVID-19

URL: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/OSE%20Review_Hydroxychloroquine-Cholorquine%20-%2019May2020_Redacted.pdf

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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Title: FDA Guidance on Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency | FDA

URL: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-guidance-conduct-clinical-trials-medical-products-during-covid-19-public-health-emergency

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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Page 1 of 1 (2 Total Results)