LEADER 04603nam 2200673 a 450 001 9910781607803321 005 20230725051529.0 010 $a0-309-21493-9 010 $a1-283-25354-2 010 $a9786613253545 010 $a0-309-21491-2 035 $a(CKB)2550000000051836 035 $a(EBL)3378855 035 $a(SSID)ssj0000533788 035 $a(PQKBManifestationID)11319018 035 $a(PQKBTitleCode)TC0000533788 035 $a(PQKBWorkID)10504138 035 $a(PQKB)10851009 035 $a(MiAaPQ)EBC3378855 035 $a(Au-PeEL)EBL3378855 035 $a(CaPaEBR)ebr10495455 035 $a(CaONFJC)MIL325354 035 $a(OCoLC)923284117 035 $a(EXLCZ)992550000000051836 100 $a20111003d2011 uy 0 101 0 $aeng 135 $auruz#---auuu| 181 $ctxt$2rdacontent 182 $cc$2rdamedia 183 $acr$2rdacarrier 200 00$aAdvancing regulatory science for medical countermeasure development$b[electronic resource] $eworkshop summary /$fTheresa Wizemann, Bruce M. Altevogt, and Anne B. Claiborne, rapporteurs 210 $aWashington, D.C. $cNational Academies Press$d2011 215 $a1 online resource (150 pages) 300 $aDescription based upon print version of record. 311 $a0-309-21490-4 320 $aIncludes bibliographical references. 327 $a""Front Matter""; ""Reviewers""; ""Contents""; ""Tables, Figures, and Boxes""; ""Acronyms""; ""1 Introduction""; ""2 MCM Enterprise and Stakeholder Perspectives""; ""3 Cutting-Edge Efforts to Advance MCM Regulatory Science""; ""4 MCM Regulatory Science Needs for At-Risk Populations""; ""5 Crosscutting Themes and Future Directions""; ""6 Closing Remarks""; ""References""; ""Appendix A: Workshop Agenda""; ""Appendix B: Participant Biographies"" 330 $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. 606 $aEmergency management$zUnited States$xEvaluation$vCongresses 606 $aDisaster medicine$zUnited States$xEvaluation$vCongresses 606 $aWeapons of mass destruction$xHealth aspects$vCongresses 606 $aChemical agents (Munitions)$vCongresses 615 0$aEmergency management$xEvaluation 615 0$aDisaster medicine$xEvaluation 615 0$aWeapons of mass destruction$xHealth aspects 615 0$aChemical agents (Munitions) 676 $a616.0250973 701 $aWizemann$b Theresa M$0890630 701 $aAltevogt$b Bruce M$01478507 701 $aClaiborne$b Anne B$01471735 712 02$aInstitute of Medicine (U.S.).$bForum on Drug Discovery, Development, and Translation. 712 02$aInstitute of Medicine (U.S.).$bForum on Medical and Public Health Preparedness for Catastrophic Events. 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910781607803321 996 $aAdvancing regulatory science for medical countermeasure development$93754755 997 $aUNINA