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Browse Items (29 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: CITI Program
Subject: Laboratory
Item Type: Hyperlink
Date Last Updated: 2022
Description: The Collaborative Institutional Training Initiative (CITI Program) is dedicated to serving the training needs of colleges and universities, healthcare institutions, technology and research organizations, and governmental agencies, as they foster… -
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… -
Creator: Kimon C Zachary, Erica S Shenoy
Subject: Infection Control
Item Type: Publication
Date Last Updated: 2022-06-09
Description: Transmission risk of monkeypox in healthcare settings outside endemic regions has not been well defined. A rapid review of the literature, including cases outside monkeypox-endemic regions from 2000 to 2022 identified a single reported case of… -
Creator: Theodore J Cieslak, Jocelyn J Herstein, Mark G Kortepeter, Angela L Hewlett
Subject: Treatment & Care
Item Type: Publication
Date Last Updated: 2019-08-22
Description: Although the concept of high-level containment care (HLCC or ‘biocontainment’), dates back to 1969, the 2014–2016 outbreak of Ebola virus disease (EVD) brought with it a renewed emphasis on the use of specialized HLCC units in the care of patients… -
Creator: Vikramjit Mukherjee, Lauren M Sauer, Aneesh K Mehta, Sophia Y Shea, Paul D Biddinger, Brendan G Carr, Laura E Evans, Shelly Schwedhelm, John J Lowe, John J Lowe
Subject: Emergency Management
Item Type: Publication
Date Last Updated: 2022-05-31
Description: Infectious disease outbreaks and pandemics have repeatedly threatened public health and have severely strained healthcare delivery systems throughout the past century. Pathogens causing respiratory illness, such as influenza viruses and… -
Creator: Ward, Brian J., Alexander Makarkov, Annie Séguin, Stéphane Pillet, Sonia Trépanier, Jiwanjeet Dhaliwall, Michael D. Libman, Timo Vesikari, and Nathalie Landry.
Subject: Laboratory
Item Type: Publication
Date Last Updated: 2020-10-13
Description: Seasonal influenza remains a substantial public health threat despite the availability of egg-derived and other vaccines. Plant-based manufacturing might address some of the limitations of current vaccines. We describe two phase 3 efficacy studies of…
