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Browse Items (841 total)
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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: 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: 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: 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: 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… -
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