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Advancing Regulatory Science for Medical Countermeasure Development - Workshop Summary (Paperback)
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Advancing Regulatory Science for Medical Countermeasure Development - Workshop Summary (Paperback)
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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. Table
of Contents Front Matter 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
General
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