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Browse Items (330 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: Editor Bruce Hawkins
Subject: Research
Item Type: Publication
Date Last Updated: 2019
Description: The purpose of these guidelines is to describe a standardized approach for the management of investigational drug products by the clinical research pharmacy, pharmaceutical industry, and cooperative and research network groups. -
Creator: Jocelyn J Herstein, Paul D Biddinger, Shawn G Gibbs, Angela L Hewlett, Aurora B Le, Michelle M Schwedhelm, John J Lowe
Subject: Research
Item Type: Publication
Date Last Updated: 2022-02-22
Description: In response to the 2014-2016 West Africa Ebola virus disease (EVD) epidemic, the Centers for Disease Control and Prevention (CDC) designated 56 US hospitals as Ebola treatment centers (ETCs) with high-level isolation capabilities. We aimed to… -
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… -
Creator: Li, L., L. B. Robinson, R. Patel, A. B. Landman, X. Fu, E. S. Shenoy, D. M. Hashimoto, A. Banerji, P. G. Wickner, U. Samarakoon, C. M. Mancini, Y. Zhang, and K. G. Blumenthal.
Subject: Research
Item Type: Publication
Date Last Updated: 2021-10-01
Description: Allergic history in individuals with confirmed anaphylaxis to a messenger RNA (mRNA) COVID-19 vaccine is common. However, the risk factors for allergy symptoms after receiving the vaccine are unknown. -
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