Advancing Regulatory Science For Medical Countermeasure Development

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Advancing Regulatory Science for Medical Countermeasure Development

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309214904
Total Pages : 150 pages
Book Rating : 4.3/5 (92 download)

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Book Synopsis Advancing Regulatory Science for Medical Countermeasure Development by : Institute of Medicine

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.

Advancing Regulatory Science for Public Health

Author : Barry Leonard
Publisher : DIANE Publishing
ISBN 13 : 1437941354
Total Pages : 20 pages
Book Rating : 4.4/5 (379 download)

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Book Synopsis Advancing Regulatory Science for Public Health by : Barry Leonard

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.

Advancing the Discipline of Regulatory Science for Medical Product Development

Author : National Academies of Sciences, Engineering, and Medicine
Publisher : National Academies Press
ISBN 13 : 0309438845
Total Pages : 105 pages
Book Rating : 4.3/5 (94 download)

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Book Synopsis Advancing the Discipline of Regulatory Science for Medical Product Development by : National Academies of Sciences, Engineering, and Medicine

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 2016-08-11 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.

The Nation's Medical Countermeasure Stockpile

Author : National Academies of Sciences, Engineering, and Medicine
Publisher : National Academies Press
ISBN 13 : 0309443709
Total Pages : 143 pages
Book Rating : 4.3/5 (94 download)

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Book Synopsis The Nation's Medical Countermeasure Stockpile by : National Academies of Sciences, Engineering, and Medicine

Download or read book The Nation's Medical Countermeasure Stockpile written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2016-10-24 with total page 143 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Medical Countermeasures Dispensing

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309186501
Total Pages : 95 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Medical Countermeasures Dispensing by : Institute of Medicine

Download or read book Medical Countermeasures Dispensing written by Institute of Medicine and published by National Academies Press. This book was released on 2010-12-16 with total page 95 pages. Available in PDF, EPUB and Kindle. Book excerpt: During public health emergencies such as terrorist attacks or influenza outbreaks, the public health system's ability to save lives could depend on dispensing medical countermeasures such as antibiotics, antiviral medications, and vaccines to a large number of people in a short amount of time. The IOM's Forum on Medical and Public Health Preparedness for Catastrophic Events held a workshop on November 18, 2009, to provide an overview of current threats, recent progress made in the public health system for distributing and dispensing countermeasures, and remaining vulnerabilities.

Animal Models for Assessing Countermeasures to Bioterrorism Agents

Author : National Research Council
Publisher : National Academies Press
ISBN 13 : 0309219124
Total Pages : 152 pages
Book Rating : 4.3/5 (92 download)

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Book Synopsis Animal Models for Assessing Countermeasures to Bioterrorism Agents by : National Research Council

Download or read book Animal Models for Assessing Countermeasures to Bioterrorism Agents written by National Research Council and published by National Academies Press. This book was released on 2011-12-09 with total page 152 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Ensuring an Effective Public Health Emergency Medical Countermeasures Enterprise

Author : National Academies of Sciences, Engineering, and Medicine
Publisher :
ISBN 13 : 9780309271486
Total Pages : 150 pages
Book Rating : 4.2/5 (714 download)

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Book Synopsis Ensuring an Effective Public Health Emergency Medical Countermeasures Enterprise by : National Academies of Sciences, Engineering, and Medicine

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.

Continuous Manufacturing for the Modernization of Pharmaceutical Production

Author : National Academies of Sciences, Engineering, and Medicine
Publisher : National Academies Press
ISBN 13 : 0309487811
Total Pages : 69 pages
Book Rating : 4.3/5 (94 download)

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Book Synopsis Continuous Manufacturing for the Modernization of Pharmaceutical Production by : National Academies of Sciences, Engineering, and Medicine

Download or read book Continuous Manufacturing for the Modernization of Pharmaceutical Production written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2019-04-05 with total page 69 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations for 2012

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.:/5 (319 download)

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Book Synopsis Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations for 2012 by : United States. Congress. House. Committee on Appropriations. Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies

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:

Pandemics, Pills, and Politics

Author : Stefan Elbe
Publisher : JHU Press
ISBN 13 : 1421425599
Total Pages : 281 pages
Book Rating : 4.4/5 (214 download)

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Book Synopsis Pandemics, Pills, and Politics by : Stefan Elbe

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.

Bioterrorism, Controlled Substances, and Public Health Issues

Author : United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health
Publisher :
ISBN 13 :
Total Pages : 168 pages
Book Rating : 4.:/5 (319 download)

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Book Synopsis Bioterrorism, Controlled Substances, and Public Health Issues by : United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health

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:

Science, the Endless Frontier

Author : Vannevar Bush
Publisher : Princeton University Press
ISBN 13 : 069120165X
Total Pages : 186 pages
Book Rating : 4.6/5 (912 download)

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Book Synopsis Science, the Endless Frontier by : Vannevar Bush

Download or read book Science, the Endless Frontier written by Vannevar Bush and published by Princeton University Press. This book was released on 2021-02-02 with total page 186 pages. Available in PDF, EPUB and Kindle. Book excerpt: The classic case for why government must support science—with a new essay by physicist and former congressman Rush Holt on what democracy needs from science today Science, the Endless Frontier is recognized as the landmark argument for the essential role of science in society and government’s responsibility to support scientific endeavors. First issued when Vannevar Bush was the director of the US Office of Scientific Research and Development during the Second World War, this classic remains vital in making the case that scientific progress is necessary to a nation’s health, security, and prosperity. Bush’s vision set the course for US science policy for more than half a century, building the world’s most productive scientific enterprise. Today, amid a changing funding landscape and challenges to science’s very credibility, Science, the Endless Frontier resonates as a powerful reminder that scientific progress and public well-being alike depend on the successful symbiosis between science and government. This timely new edition presents this iconic text alongside a new companion essay from scientist and former congressman Rush Holt, who offers a brief introduction and consideration of what society needs most from science now. Reflecting on the report’s legacy and relevance along with its limitations, Holt contends that the public’s ability to cope with today’s issues—such as public health, the changing climate and environment, and challenging technologies in modern society—requires a more capacious understanding of what science can contribute. Holt considers how scientists should think of their obligation to society and what the public should demand from science, and he calls for a renewed understanding of science’s value for democracy and society at large. A touchstone for concerned citizens, scientists, and policymakers, Science, the Endless Frontier endures as a passionate articulation of the power and potential of science.

Determining Core Capabilities in Chemical and Biological Defense Science and Technology

Author : National Research Council
Publisher : National Academies Press
ISBN 13 : 0309265355
Total Pages : 141 pages
Book Rating : 4.3/5 (92 download)

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Book Synopsis Determining Core Capabilities in Chemical and Biological Defense Science and Technology by : National Research Council

Download or read book Determining Core Capabilities in Chemical and Biological Defense Science and Technology written by National Research Council and published by National Academies Press. This book was released on 2013-01-13 with total page 141 pages. Available in PDF, EPUB and Kindle. Book excerpt: The goal of the U.S. Department of Defense's (DoD's) Chemical and Biological Defense Program (CBDP) is to provide support and world-class capabilities enabling he U.S. Armed Forces to fight and win decisively in chemical, biological, radiological, and nuclear (CBRN) environments. To accomplish this objective, the CBDP must maintain robust science and technology capabilities to support the research, development, testing, and evaluation required for the creation and validation of the products the program supplies. The threat from chemical and biological attack evolves due to the changing nature of conflict and rapid advances in science and technology (S&T), so the core S&T capabilities that must be maintained by the CBDP must also continue to evolve. In order to address the challenges facing the DoD, the Deputy Assistant Secretary of Defense (DASD) for Chemical and Biological Defense (CBD) asked the National Research Council (NRC) to conduct a study to identify the core capabilities in S&T that must be supported by the program. The NRC Committee on Determining Core Capabilities in Chemical and Biological Defense Research and Development examined the capabilities necessary for the chemical and biological defense S&T program in the context of the threat and of the program's stated mission and priorities. Determining Core Capabilities in Chemical and Biological Defense Science and Technology contains the committee's findings and recommendations. It is intended to assist the DASD CBD in determining the best strategy for acquiring, developing, and/or maintaining the needed capabilities.

Biological Collections

Author : National Academies of Sciences, Engineering, and Medicine
Publisher : National Academies Press
ISBN 13 : 0309498538
Total Pages : 245 pages
Book Rating : 4.3/5 (94 download)

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Book Synopsis Biological Collections by : National Academies of Sciences, Engineering, and Medicine

Download or read book Biological Collections written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2021-01-29 with total page 245 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biological collections are a critical part of the nation's science and innovation infrastructure and a fundamental resource for understanding the natural world. Biological collections underpin basic science discoveries as well as deepen our understanding of many challenges such as global change, biodiversity loss, sustainable food production, ecosystem conservation, and improving human health and security. They are important resources for education, both in formal training for the science and technology workforce, and in informal learning through schools, citizen science programs, and adult learning. However, the sustainability of biological collections is under threat. Without enhanced strategic leadership and investments in their infrastructure and growth many biological collections could be lost. Biological Collections: Ensuring Critical Research and Education for the 21st Century recommends approaches for biological collections to develop long-term financial sustainability, advance digitization, recruit and support a diverse workforce, and upgrade and maintain a robust physical infrastructure in order to continue serving science and society. The aim of the report is to stimulate a national discussion regarding the goals and strategies needed to ensure that U.S. biological collections not only thrive but continue to grow throughout the 21st century and beyond.

Departments of Labor, Health and Human Services, Education, and Related Agencies Appropriations for 2016

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.F/5 ( download)

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Book Synopsis Departments of Labor, Health and Human Services, Education, and Related Agencies Appropriations for 2016 by : United States. Congress. House. Committee on Appropriations. Subcommittee on the Departments of Labor, Health and Human Services, Education, and Related Agencies

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:

Prepositioning Antibiotics for Anthrax

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 030921808X
Total Pages : 358 pages
Book Rating : 4.3/5 (92 download)

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Book Synopsis Prepositioning Antibiotics for Anthrax by : Institute of Medicine

Download or read book Prepositioning Antibiotics for Anthrax written by Institute of Medicine and published by National Academies Press. This book was released on 2012-02-26 with total page 358 pages. Available in PDF, EPUB and Kindle. Book excerpt: If terrorists released Bacillus anthracis over a large city, hundreds of thousands of people could be at risk of the deadly disease anthrax-caused by the B. anthracis spores-unless they had rapid access to antibiotic medical countermeasures (MCM). Although plans for rapidly delivering MCM to a large number of people following an anthrax attack have been greatly enhanced during the last decade, many public health authorities and policy experts fear that the nation's current systems and plans are insufficient to respond to the most challenging scenarios, such as a very large-scale anthrax attack. The U.S. Department of Health and Human Services' Office of the Assistant Secretary for Preparedness and Response commissioned the Institute of Medicine to examine the potential uses, benefits, and disadvantages of strategies for repositioning antibiotics. This involves storing antibiotics close to or in the possession of the people who would need rapid access to them should an attack occur. Prepositioning Antibiotics for Anthrax reviews the scientific evidence on the time window in which antibiotics successfully prevent anthrax and the implications for decision making about prepositioning, describes potential prepositioning strategies, and develops a framework to assist state, local, and tribal public health authorities in determining whether prepositioning strategies would be beneficial for their communities. However, based on an analysis of the likely health benefits, health risks, and relative costs of the different prepositioning strategies, the book also develops findings and recommendations to provide jurisdictions with some practical insights as to the circumstances in which different prepositioning strategies may be beneficial. Finally, the book identifies federal- and national-level actions that would facilitate the evaluation and development of prepositioning strategies. Recognizing that communities across the nation have differing needs and capabilities, the findings presented in this report are intended to assist public health officials in considering the benefits, costs, and trade-offs involved in developing alternative prepositioning strategies appropriate to their particular communities.

Ethical and Scientific Issues in Studying the Safety of Approved Drugs

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309218160
Total Pages : 292 pages
Book Rating : 4.3/5 (92 download)

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Book Synopsis Ethical and Scientific Issues in Studying the Safety of Approved Drugs by : Institute of Medicine

Download or read book Ethical and Scientific Issues in Studying the Safety of Approved Drugs written by Institute of Medicine and published by National Academies Press. This book was released on 2012-07-30 with total page 292 pages. Available in PDF, EPUB and Kindle. Book excerpt: An estimated 48 percent of the population takes at least one prescription drug in a given month. Drugs provide great benefits to society by saving or improving lives. Many drugs are also associated with side effects or adverse events, some serious and some discovered only after the drug is on the market. The discovery of new adverse events in the postmarketing setting is part of the normal natural history of approved drugs, and timely identification and warning about drug risks are central to the mission of the Food and Drug Administration (FDA). Not all risks associated with a drug are known at the time of approval, because safety data are collected from studies that involve a relatively small number of human subjects during a relatively short period. Written in response to a request by the FDA, Ethical and Scientific Issues in Studying the Safety of Approved Drugs discusses ethical and informed consent issues in conducting studies in the postmarketing setting. It evaluates the strengths and weaknesses of various approaches to generate evidence about safety questions, and makes recommendations for appropriate followup studies and randomized clinical trials. The book provides guidance to the FDA on how it should factor in different kinds of evidence in its regulatory decisions. Ethical and Scientific Issues in Studying the Safety of Approved Drugs will be of interest to the pharmaceutical industry, patient advocates, researchers, and consumer groups.