Advancing regulatory science for medical countermeasure development : workshop summary

Advancing regulatory science for medical countermeasure development : workshop summary /

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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 a...

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Bibliographic Details
Online Access: Full text (MCPHS users only)
Corporate Authors: 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
Other Authors: Wizemann, Theresa M., Altevogt, Bruce M., Claiborne, Anne B.
Format: Electronic eBook
Language:English
Published: Washington, D.C. : Natlional Academies Press, 2011
Subjects:
United States. > Food and Drug Administration > Congresses.
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
United States
Congress
proceedings (reports)
Conference papers and proceedings.
Local Note:ProQuest Ebook Central
Description
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
Physical Description:1 online resource (xviii, 132 pages) : illustrations
Bibliography:Includes bibliographical references (pages 81-82).
ISBN:9780309214919
0309214912
1283253542
9781283253543
9786613253545
6613253545
Language:English.
Source of Description, Etc. Note:Print version record.

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