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Browse Items (103 total)
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Creator: FDA
Subject: Research
Item Type: Hyperlink
Date Last Updated: 2023-05-12
Description: The Emergency Use Authorization (EUA) authority allows FDA to help strengthen the nation’s public health protections against chemical, biological, radiological, and nuclear (CBRN) threats including infectious diseases, by facilitating the… -
Creator: FDA
Subject: Research
Item Type: Hyperlink
Date Last Updated: 2022-07-20
Description: Current Federal law requires that a drug be the subject of an approved marketing application before it is transported or distributed across state lines. Because a sponsor will probably want to ship the investigational drug to clinical investigators… -
Creator: Abigail E Lowe, Colleen Kraft, Mark G Kortepeter, Keith F Hansen, Kristine Sanger, Ann Johnson, Jonathan D Grein, Julie Martin, Rebecca Rousselle, Jennifer A Garland, Jessica Spotts, John J Lowe, Lauren M Sauer, Christopher J Kratochvil, Bruce G…
Subject: Research
Item Type: Publication
Date Last Updated: 2022-05-31
Description: Research is foundational for evidence-based management of patients. Clinical research, however, takes time to plan, conduct, and disseminate—a luxury that is rarely available during a public health emergency. The University of Nebraska Medical Center… -
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Creator: Shantha, J. G., I. Crozier, C. S. Kraft, D. G. Grant, A. Goba, B. R. Hayek, C. Hartley, K. G. Barnes, T. M. Uyeki, J. Schieffelin, R. F. Garry, D. G. Bausch, P. E. Farmer, J. G. Mattia, M. J. Vandy, and S. Yeh.
Subject: Research
Item Type: Publication
Date Last Updated: 2021-07-09
Description: Following the West African Ebola virus disease (EVD) outbreak of 2013-2016 and more recent EVD outbreaks in the Democratic Republic of Congo, thousands of EVD survivors are at-risk for sequelae including uveitis, which can lead to unremitting… -
Creator: FDA
Subject: Research
Item Type: Hyperlink
Date Last Updated: 2021-05
Description: Guidance for Sponsors, Clinical Investigators, and IRBs. Information for investigational new drugs (IND).
Draft Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs Frequently Asked Questions Statement of Investigator (Form FDA… -
Creator: Mbala-Kingebeni, Placide, Catherine Pratt, Mbusa Mutafali-Ruffin, Matthias G. Pauthner, Faustin Bile, Antoine Nkuba-Ndaye, Allison Black, Eddy Kinganda-Lusamaki, Martin Faye, Amuri Aziza, Moussa M. Diagne, Daniel Mukadi, Bailey White, James Hadfield,…
Subject: Research
Item Type: Publication
Date Last Updated: 2021-03-31
Description: During the 2018–2020 Ebola virus disease (EVD) outbreak in North Kivu province in the Democratic Republic of Congo, EVD was diagnosed in a patient who had received the recombinant vesicular stomatitis virus–based vaccine expressing a ZEBOV…
