MARC Record from Library of Congress

LEADER: 03642cam a2200397 a 4500
001 2011499600
003 DLC
005 20120105105859.0
008 111107s2011 dcua b 100 0 eng c
010 $a 2011499600
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020 $a0309214904 (pbk.)
035 $a(OCoLC)ocn744284130
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050 00 $aRA645.5$b.A287 2011
082 00 $a363.340973$223
245 00 $aAdvancing regulatory science for medical countermeasure development :$bworkshop summary /$cTheresa 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.
260 $aWashington, D.C. :$bNatlional Academies Press,$cc2011.
300 $axviii, 132 p. :$bill. (some col.) ;$c23 cm.
520 $aWhether 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.
504 $aIncludes bibliographical references (p. 81-82).
530 $aAlso available online in Open Book format via the National Academies Press home page.
610 10 $aUnited States.$bFood and Drug Administration$vCongresses.
650 0 $aEmergency management$zUnited States$xEvaluation$vCongresses.
650 0 $aDisaster medicine$zUnited States$xEvaluation$vCongresses.
650 0 $aWeapons of mass destruction$xHealth aspects$vCongresses.
650 0 $aChemical agents (Munitions)$vCongresses.
700 1 $aWizemann, Theresa M.
700 1 $aAltevogt, Bruce M.
700 1 $aClaiborne, Anne B.
710 2 $aInstitute of Medicine (U.S.).$bForum on Drug Discovery, Development, and Translation.
710 2 $aInstitute of Medicine (U.S.).$bForum on Medical and Public Health Preparedness for Catastrophic Events.
856 41 $uhttp://www.nap.edu/catalog.php?record_id=13173