Advancing Regulatory Science For Medical Countermeasure Development

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309214904
Total Pages : 150 pages
Book Rating : 4.02/5 ( download)

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Download or read book Advancing Regulatory Science for Medical Countermeasure Development written by Institute of Medicine and published by National Academies Press. This book was released on 2011-08-27 with total page 150 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Author : Barry Leonard
Publisher : DIANE Publishing
ISBN 13 : 1437941354
Total Pages : 20 pages
Book Rating : 4.57/5 ( download)

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Download or read book Advancing Regulatory Science for Public Health written by Barry Leonard and published by DIANE Publishing. This book was released on 2011 with total page 20 pages. Available in PDF, EPUB and Kindle. Book excerpt: This is a print on demand edition of a hard to find publication. Recent breakthroughs in science and tech. -- ranging from sequencing of the human genome to advances in the application of nanotech. to new medical products -- may transform our ability to prevent, diagnose and treat disease. Similarly, advances in research and IT enable us to more efficiently identify microbial pathogens, track food contamination outbreaks and determine where foods and other FDA-regulated products are produced or manufactured, how they are transported, where they go and who uses them. This report outlines a broad vision for advancing regulatory science and unleashing its potential to improve public health. It discusses the role of the FDA to strengthen the field, both within the agency and throughout the Nation. Illustrations.

Author : National Academies of Sciences, Engineering, and Medicine
Publisher : National Academies Press
ISBN 13 : 030943887X
Total Pages : 105 pages
Book Rating : 4.72/5 ( download)

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Download or read book Advancing the Discipline of Regulatory Science for Medical Product Development written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2016-07-11 with total page 105 pages. Available in PDF, EPUB and Kindle. Book excerpt: The field of endeavors known as "regulatory science" has grown out of the need to link and integrate knowledge within and among basic science research, clinical research, clinical medicine, and other specific scientific disciplines whose focus, aggregation, and ultimate implementation could inform biomedical product development and regulatory decision making. Substantial efforts have been devoted to defining regulatory science and communicating its value and role across the scientific and regulatory ecosystems. Investments are also being made in technology infrastructure, regulatory systems, and workforce development to support and advance this burgeoning discipline. In October 2015, the National Academies of Sciences, Engineering, and Medicine held a public workshop to facilitate dialogue among stakeholders about the current state and scope of regulatory science, opportunities to address barriers to the discipline's success, and avenues for fostering collaboration across sectors. Participants explored key needs for strengthening the discipline of regulatory science, including considering what are the core components of regulatory science infrastructure to foster innovation in medical product development. This report summarizes the presentations and discussions from the workshop.

Author : United States. Congress. House. Committee on Appropriations. Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies
Publisher :
ISBN 13 :
Total Pages : 860 pages
Book Rating : 4.4P/5 ( download)

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Download or read book Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations for 2012 written by United States. Congress. House. Committee on Appropriations. Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies and published by . This book was released on 2011 with total page 860 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Author : National Academies of Sciences, Engineering, and Medicine
Publisher :
ISBN 13 : 9780309271486
Total Pages : 150 pages
Book Rating : 4.87/5 ( download)

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Download or read book Ensuring an Effective Public Health Emergency Medical Countermeasures Enterprise written by National Academies of Sciences, Engineering, and Medicine and published by . This book was released on 2022-08-03 with total page 150 pages. Available in PDF, EPUB and Kindle. Book excerpt: The U.S. medical countermeasures (MCMs) enterprise is interconnected, complex, and dynamic. It includes public and private entities that develop and manufacture new and existing MCMs, ensure procurement, storage, and distribution of MCMs, and administer, monitor, and evaluate MCMs. The interagency group known as the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) is the nation's sole coordinating body, responsible for ensuring end-to-end MCM preparedness and response. Ensuring an Effective Public Health Emergency Medical Countermeasures Enterprise provides recommendations from an expert committee for a re-envisioned PHEMCE. Four priority areas of improvement emerged from committee deliberations: (1) articulating PHEMCE's mission and role and explicating the principles guiding PHEMCE's operating principles and processes, (2) revising PHEMCE operations and processes, (3) collaborating more effectively with external public and private partners, and (4) navigating legal and policy issues.

Author : United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health
Publisher :
ISBN 13 :
Total Pages : 168 pages
Book Rating : 4.44/5 ( download)

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Download or read book Bioterrorism, Controlled Substances, and Public Health Issues written by United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health and published by . This book was released on 2012 with total page 168 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Author : United States. Congress. House. Committee on Appropriations. Subcommittee on the Departments of Labor, Health and Human Services, Education, and Related Agencies
Publisher :
ISBN 13 :
Total Pages : 1292 pages
Book Rating : 4.71/5 ( download)

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Download or read book Departments of Labor, Health and Human Services, Education, and Related Agencies Appropriations for 2016 written by United States. Congress. House. Committee on Appropriations. Subcommittee on the Departments of Labor, Health and Human Services, Education, and Related Agencies and published by . This book was released on 2015 with total page 1292 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309215366
Total Pages : 203 pages
Book Rating : 4.67/5 ( download)

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Download or read book Informing the Future written by Institute of Medicine and published by National Academies Press. This book was released on 2011-10-12 with total page 203 pages. Available in PDF, EPUB and Kindle. Book excerpt: This report illustrates the work of IOM committees in selected, major areas in recent years, followed by a description of IOM's convening and collaborative activities and fellowship programs. The last section provides a comprehensive bibliography of IOM reports published since 2007.

Author : Stefan Elbe
Publisher : JHU Press
ISBN 13 : 1421425599
Total Pages : 281 pages
Book Rating : 4.97/5 ( download)

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Download or read book Pandemics, Pills, and Politics written by Stefan Elbe and published by JHU Press. This book was released on 2018-06-01 with total page 281 pages. Available in PDF, EPUB and Kindle. Book excerpt: The fascinating story of Tamiflu's development and stockpiling against global health threats.orld's most prominent medical countermeasure, Tamiflu. A pill can strengthen national security? The suggestion may seem odd, but many states around the world believe precisely that. Confronted with pandemics, bioterrorism, and emerging infectious diseases, governments are transforming their security policies to include the proactive development, acquisition, stockpiling, and mass distribution of new pharmaceutical defenses. What happens—politically, economically, and socially—when governments try to protect their populations with pharmaceuticals? How do competing interests among states, pharmaceutical companies, regulators, and scientists play out in the quest to develop new medical countermeasures? And do citizens around the world ultimately stand to gain or lose from this pharmaceuticalization of security policy? Stefan Elbe explores these complex questions in Pandemics, Pills, and Politics, the first in-depth study of the world’s most prominent medical countermeasure, Tamiflu. Taken by millions of people around the planet in the fight against pandemic flu, Tamiflu has provoked suspicions about undue commercial influence in government decision-making about stockpiles. It even found itself at the center of a prolonged political battle over who should have access to the data about the safety and effectiveness of medicines. Pandemics, Pills, and Politics shows that the story of Tamiflu harbors deeper lessons about the vexing political, economic, legal, social, and regulatory tensions that emerge as twenty-first-century security policy takes a pharmaceutical turn. At the heart of this issue, Elbe argues, lies something deeper: the rise of a new molecular vision of life that is reshaping the world we live in.

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 030918634X
Total Pages : 604 pages
Book Rating : 4.46/5 ( download)

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Download or read book The Causes and Impacts of Neglected Tropical and Zoonotic Diseases written by Institute of Medicine and published by National Academies Press. This book was released on 2011-07-01 with total page 604 pages. Available in PDF, EPUB and Kindle. Book excerpt: Neglected tropical diseases (NTDs) afflict more than 1.4 billion people, many of whom live on less than $1.25 a day. While there are effective ways to manage NTDs, policy-makers and funders have only recently begun to recognize the economic and public health importance of controlling NTDs. The IOM's Forum on Microbial Threats held a workshop September 21-22, 2010, to discuss the science of and policy surrounding NTDs.