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Navegar por los elementos (103 total)
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Autor: Occupational Safety and Health Administration (OSHA)
Tema: Research
Tipo de elemento: Guía
Fecha de actualización: 2011
Descripción: This publication provides a general overview of a particular standards-related topic. This publication does not alter or determine compliance responsibilities which are set forth in OSHA standards, and the Occupational Safety and Health Act of 1970.… -
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Autor: FDA
Tema: Research
Tipo de elemento: Hipervínculo
Fecha de actualización: 2023-05-12
Descripción: 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… -
Autor: FDA
Tema: Research
Tipo de elemento: Hipervínculo
Fecha de actualización: 2022-07-20
Descripción: 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… -
Autor: Editor Bruce Hawkins
Tema: Research
Tipo de elemento: Publicación
Fecha de actualización: 2019
Descripción: 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. -
Autor: FDA
Tema: Research
Tipo de elemento: Hipervínculo
Fecha de actualización: 2021-05
Descripción: 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… -
Autor: 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…
Tema: Research
Tipo de elemento: Publicación
Fecha de actualización: 2022-05-31
Descripción: 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… -
