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.

Cover image for 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.

ISBN:

9780309214919

9781283253543

Title:

Author:

Wizemann, Theresa M.

Publication Information:

Physical 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.

Local Note:

eBooks on EBSCOhost

Corporate Subject:

United States. Food and Drug Administration -- Congresses.

Subject Term:

Emergency management -- United States -- Evaluation -- Congresses.

Disaster medicine -- United States -- Evaluation -- Congresses.

Weapons of mass destruction -- Health aspects -- Congresses.

Chemical agents (Munitions) -- Congresses.

Geographic Term:

Added Author:

Added Corporate Author:

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.

Format:

Electronic Resources

Electronic Access:

Click here to view

Publication Date:

2011

Publication Information:

Available:*

Shelf Number	Material Type	Copy	Shelf Location	Status
362.18 23	1:E-BOOK	1	1:ONLINE	Searching... Unknown

Bound With These Titles

On Order

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.