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Advancing regulatory science for medical countermeasure development : workshop summary / Theresa Wizemann, Bruce M. Altevogt, and Anne B. Claiborne, rapporteurs ; Forum on Drug Discovery, Development, and Translation ; Forum on Medical and Public Health Preparedness for Catastropic Events, Board on Health Sciences Policy, Institute of Medicine of the National Academies
Washington, D.C. : Natlional Academies Press, c2011
book jacket
Location Call Number Status
 4th Floor  RA645.5 .A287 2011    AVAILABLE
Subject United States. Food and Drug Administration -- Congresses
Subject(s) Emergency management -- United States -- Evaluation -- Congresses
Disaster medicine -- United States -- Evaluation -- Congresses
Weapons of mass destruction -- Health aspects -- Congresses
Chemical agents (Munitions) -- Congresses
Physical Description xviii, 132 p. : ill. (some col.) ; 23 cm
Summary Whether or not the United States has safe and effective medical countermeasures--such as vaccines, drugs, and diagnostic tools--available for use during a disaster can mean the difference between life and death for many Americans. The Food and Drug Administration (FDA) and the scientific community at large could benefit from improved scientific tools and analytic techniques to undertake the complex scientific evaluation and decision making needed to make essential medical countermeasures available. At the request of FDA, the Institute of Medicine (IOM) held a workshop to examine methods to improve the development, evaluation, approval, and regulation of medical countermeasures. During public health emergencies such as influenza or chemical, biological, radiological/nuclear (CBRN) attacks, safe and effective vaccines, treatments, and other medical countermeasures are essential to protecting national security and the well being of the public. Advancing regulatory science for medical countermeasure development examines current medical countermeasures, and investigates the future of research and development in this area. Convened on March 29-30, 2011, this workshop identified regulatory science tools and methods that are available or under development, as well as major gaps in currently available regulatory science tools. Advancing regulatory science for medical countermeasure development is a valuable resource for federal agencies including the Food and Drug Administration (FDA), the Department of Health and Human Services (HHS), the Department of Defense (DoD), as well as health professionals, and public and private health organizations"--Publisher's description
Note Includes bibliographical references (p. 81-82)
Alternate Author Wizemann, Theresa M
Altevogt, Bruce M
Claiborne, Anne B
Institute of Medicine (U.S.). Forum on Drug Discovery, Development, and Translation
Institute of Medicine (U.S.). Forum on Medical and Public Health Preparedness for Catastrophic Events

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