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Title 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 PreparadnessforCatastropicEvents, Board on Health Sciences Policy, Institute of Medicine of the National Academies
Published Washington, D.C. : Natlional Academies Press, ©2011

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Description 1 online resource (xviii, 132 pages) : illustrations
Contents Introduction -- MCM enterprise and stakeholder perspectives -- Cutting-edge efforts to advance MCM regulatory science -- MCM regulatory science needs for at-risk populations -- Crosscutting themes and future directions -- Closing remarks
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
Bibliography Includes bibliographical references (pages 81-82)
Notes English
Print version record
Subject United States. Food and Drug Administration -- Congresses
SUBJECT United States. Food and Drug Administration fast
Subject Emergency management -- United States -- Evaluation -- Congresses
Disaster medicine -- United States -- Evaluation -- Congresses
Weapons of mass destruction -- Health aspects -- Congresses
Chemical agents (Munitions) -- Congresses
Disaster Planning -- organization & administration
Emergency Medical Services -- organization & administration
HEALTH & FITNESS -- First Aid.
MEDICAL -- Allied Health Services -- Emergency Medical Services.
Chemical agents (Munitions)
Emergency management -- Evaluation
SUBJECT United States https://id.nlm.nih.gov/mesh/D014481
Subject United States
Genre/Form proceedings (reports)
Conference papers and proceedings
Conference papers and proceedings.
Actes de congrès.
Form Electronic book
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.
ISBN 9780309214919
0309214912
1283253542
9781283253543
9786613253545
6613253545