Advancing Regulatory Science For Medical Countermeasure Development
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Advancing Regulatory Science For Medical Countermeasure Development
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Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 2011-08-27
Advancing Regulatory Science For Medical Countermeasure Development written by Institute of Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2011-08-27 with Medical categories.
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.
Advancing Regulatory Science For Public Health
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Author : Barry Leonard
language : en
Publisher: DIANE Publishing
Release Date : 2011
Advancing Regulatory Science For Public Health written by Barry Leonard and has been published by DIANE Publishing this book supported file pdf, txt, epub, kindle and other format this book has been release on 2011 with Health & Fitness categories.
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.
Advancing The Discipline Of Regulatory Science For Medical Product Development
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Author : National Academies of Sciences, Engineering, and Medicine
language : en
Publisher: National Academies Press
Release Date : 2016-07-11
Advancing The Discipline Of Regulatory Science For Medical Product Development written by National Academies of Sciences, Engineering, and Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-07-11 with Medical categories.
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.
Agriculture Rural Development Food And Drug Administration And Related Agencies Appropriations For 2012
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Author : United States. Congress. House. Committee on Appropriations. Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies
language : en
Publisher:
Release Date : 2011
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 has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2011 with United States categories.
The Nation S Medical Countermeasure Stockpile
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Author : National Academies of Sciences, Engineering, and Medicine
language : en
Publisher: National Academies Press
Release Date : 2016-10-24
The Nation S Medical Countermeasure Stockpile written by National Academies of Sciences, Engineering, and Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-10-24 with Medical categories.
Large catastrophic events, or rare acute events, may cause situations in which a local jurisdiction's medicines and medical supplies are not sufficient to provide care to the population it serves. In these cases of natural or engineered disasters, such as a terrorist attack, influenza pandemic, or earthquake, state or local authorities can request that the federal government provide assets from the Strategic National Stockpile to augment the state and local jurisdictions' resources. The Centers for Disease Control and Prevention's (CDC's) Strategic National Stockpile (SNS) is the nation's repository of antibiotics, chemical antidotes, antitoxins, vaccines, antiviral drugs, and other medical materiel designed to supplement and resupply state and local public health agencies in the event of an emergency. The materiel is intended to support national health security and is managed by the Office of Public Health Preparedness and Response's (OPHPR's) Division of Strategic National Stockpile (DSNS). The stated mission of the SNS is to prepare and support partners and provide the right resources at the right time to secure the nation's health. The National Academies of Sciences, Engineering, and Medicine organized a two-day public workshop to explore opportunities to improve the efficiency, effectiveness, and sustainable methods used by the CDC's SNS to distribute medical countermeasures and other supplies during disasters and other public health emergencies, especially those which result in disruption of physical infrastructure such as the electrical grid, central roadways, bridges, and tunnels within the impacted community. Participants explored relevant distribution lessons learned from other federal agency stockpiles and the private sector as well as opportunities to develop public-private collaborations in the purchase, warehousing, management, and distribution of medical countermeasures. This report summarizes the presentations and discussions from the workshop.
Bioterrorism Controlled Substances And Public Health Issues
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Author : United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health
language : en
Publisher:
Release Date : 2012
Bioterrorism Controlled Substances And Public Health Issues written by United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012 with Law categories.
Animal Models For Assessing Countermeasures To Bioterrorism Agents
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Author : National Research Council
language : en
Publisher: National Academies Press
Release Date : 2011-12-09
Animal Models For Assessing Countermeasures To Bioterrorism Agents written by National Research Council and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2011-12-09 with Science categories.
The Transformational Medical Technologies (TMT) has been a unique component of the U.S. Department of Defense (DoD) medical biodefense efforts since 2006. Its mission is to advance countermeasure research and development in support of the broader goal of the DoD to protect warfighters from emerging infectious diseases and future genetically engineered biological weapons. The TMT, using advanced science and technology approaches, focused on the development of roadspectrum countermeasures that target common host and pathogen pathways or enhance the host's immune response. Many of these pathogens are lethal or cause such debilitating diseases in humans that it is ethically inappropriate to test the efficacy of these countermeasures in human volunteers. In lieu of human participants, these products may be tested in animals and approved for human use under the provisions of the Food and Drug Administration (FDA)'s 2002 Animal Rule. The reliance on animal models for the development and licensure of medical countermeasures against biothreats is challenging for a number of reasons. The ad hoc Committee on Animal Models for Assessing Countermeasures to Bioterrorism Agents prepared a consensus report that would address the challenges stemming from developing and testing medical countermeasures against biothreat agents in animal models. Animal Models for Assessing Countermeasures to Bioterrorism Agents evaluates how well the existing TMT-employed or candidate animal models reflect the pathophysiology, clinical picture, and treatment of human disease as related to the agents of interest. The report addresses the process and/or feasibility of developing new animal models for critical biodefense research, placing emphasis on the need for a robust and expeditious validation process in terms of the FDA's Animal Rule. The report also evaluates alternatives to the use of animal models based on the premise of the Three Rs.
Departments Of Labor Health And Human Services Education And Related Agencies Appropriations For 2016
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Author : United States. Congress. House. Committee on Appropriations. Subcommittee on the Departments of Labor, Health and Human Services, Education, and Related Agencies
language : en
Publisher:
Release Date : 2015
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 has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2015 with United States categories.
Continuous Manufacturing For The Modernization Of Pharmaceutical Production
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Author : National Academies of Sciences, Engineering, and Medicine
language : en
Publisher: National Academies Press
Release Date : 2019-04-05
Continuous Manufacturing For The Modernization Of Pharmaceutical Production written by National Academies of Sciences, Engineering, and Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-04-05 with Medical categories.
On July 30-31, 2018, the National Academies of Sciences, Engineering, and Medicine held a workshop titled Continuous Manufacturing for the Modernization of Pharmaceutical Production. This workshop discussed the business and regulatory concerns associated with adopting continuous manufacturing techniques to produce biologics such as enzymes, monoclonal antibodies, and vaccines. The participants also discussed specific challenges for integration across the manufacturing system, including upstream and downstream processes, analytical techniques, and drug product development. The workshop addressed these challenges broadly across the biologics domain but focused particularly on drug categories of greatest FDA and industrial interest such as monoclonal antibodies and vaccines. This publication summarizes the presentations and discussions from the workshop.
Informing The Future
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Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 2011-10-12
Informing The Future written by Institute of Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2011-10-12 with Medical categories.
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.