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Browse Items (102 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: 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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