Rare Diseases and Orphan Products

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Author :
Publisher : National Academies Press
ISBN 13 : 0309158060
Total Pages : 442 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Rare Diseases and Orphan Products by : Institute of Medicine

Download or read book Rare Diseases and Orphan Products written by Institute of Medicine and published by National Academies Press. This book was released on 2011-04-03 with total page 442 pages. Available in PDF, EPUB and Kindle. Book excerpt: Rare diseases collectively affect millions of Americans of all ages, but developing drugs and medical devices to prevent, diagnose, and treat these conditions is challenging. The Institute of Medicine (IOM) recommends implementing an integrated national strategy to promote rare diseases research and product development.

Modern Methods of Clinical Investigation

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Publisher : National Academies Press
ISBN 13 : 0309042860
Total Pages : 241 pages
Book Rating : 4.3/5 (9 download)

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Book Synopsis Modern Methods of Clinical Investigation by : Institute of Medicine

Download or read book Modern Methods of Clinical Investigation written by Institute of Medicine and published by National Academies Press. This book was released on 1990-02-01 with total page 241 pages. Available in PDF, EPUB and Kindle. Book excerpt: The very rapid pace of advances in biomedical research promises us a wide range of new drugs, medical devices, and clinical procedures. The extent to which these discoveries will benefit the public, however, depends in large part on the methods we choose for developing and testing them. Modern Methods of Clinical Investigation focuses on strategies for clinical evaluation and their role in uncovering the actual benefits and risks of medical innovation. Essays explore differences in our current systems for evaluating drugs, medical devices, and clinical procedures; health insurance databases as a tool for assessing treatment outcomes; the role of the medical profession, the Food and Drug Administration, and industry in stimulating the use of evaluative methods; and more. This book will be of special interest to policymakers, regulators, executives in the medical industry, clinical researchers, and physicians.

Registries for Evaluating Patient Outcomes

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Publisher : Government Printing Office
ISBN 13 : 1587634333
Total Pages : 385 pages
Book Rating : 4.5/5 (876 download)

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Book Synopsis Registries for Evaluating Patient Outcomes by : Agency for Healthcare Research and Quality/AHRQ

Download or read book Registries for Evaluating Patient Outcomes written by Agency for Healthcare Research and Quality/AHRQ and published by Government Printing Office. This book was released on 2014-04-01 with total page 385 pages. Available in PDF, EPUB and Kindle. Book excerpt: This User’s Guide is intended to support the design, implementation, analysis, interpretation, and quality evaluation of registries created to increase understanding of patient outcomes. For the purposes of this guide, a patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes. A registry database is a file (or files) derived from the registry. Although registries can serve many purposes, this guide focuses on registries created for one or more of the following purposes: to describe the natural history of disease, to determine clinical effectiveness or cost-effectiveness of health care products and services, to measure or monitor safety and harm, and/or to measure quality of care. Registries are classified according to how their populations are defined. For example, product registries include patients who have been exposed to biopharmaceutical products or medical devices. Health services registries consist of patients who have had a common procedure, clinical encounter, or hospitalization. Disease or condition registries are defined by patients having the same diagnosis, such as cystic fibrosis or heart failure. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews.

New Medical Devices

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Publisher : National Academies Press
ISBN 13 : 0309038472
Total Pages : 203 pages
Book Rating : 4.3/5 (9 download)

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Book Synopsis New Medical Devices by : Institute of Medicine

Download or read book New Medical Devices written by Institute of Medicine and published by National Academies Press. This book was released on 1988-01-01 with total page 203 pages. Available in PDF, EPUB and Kindle. Book excerpt: In the past 50 years the development of a wide range of medical devices has improved the quality of people's lives and revolutionized the prevention and treatment of disease, but it also has contributed to the high cost of health care. Issues that shape the invention of new medical devices and affect their introduction and use are explored in this volume. The authors examine the role of federal support, the decision-making process behind private funding, the need for reforms in regulation and product liability, the effects of the medical payment system, and other critical topics relevant to the development of new devices.

Medical Devices and the Public's Health

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Publisher : National Academies Press
ISBN 13 : 0309212421
Total Pages : 318 pages
Book Rating : 4.3/5 (92 download)

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Book Synopsis Medical Devices and the Public's Health by : Institute of Medicine

Download or read book Medical Devices and the Public's Health written by Institute of Medicine and published by National Academies Press. This book was released on 2011-11-25 with total page 318 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical devices that are deemed to have a moderate risk to patients generally cannot go on the market until they are cleared through the FDA 510(k) process. In recent years, individuals and organizations have expressed concern that the 510(k) process is neither making safe and effective devices available to patients nor promoting innovation in the medical-device industry. Several high-profile mass-media reports and consumer-protection groups have profiled recognized or potential problems with medical devices cleared through the 510(k) clearance process. The medical-device industry and some patients have asserted that the process has become too burdensome and is delaying or stalling the entry of important new medical devices to the market. At the request of the FDA, the Institute of Medicine (IOM) examined the 510(k) process. Medical Devices and the Public's Health examines the current 510(k) clearance process and whether it optimally protects patients and promotes innovation in support of public health. It also identifies legislative, regulatory, or administrative changes that will achieve the goals of the 510(k) clearance process. Medical Devices and the Public's Health recommends that the U.S. Food and Drug Administration gather the information needed to develop a new regulatory framework to replace the 35-year-old 510(k) clearance process for medical devices. According to the report, the FDA's finite resources are best invested in developing an integrated premarket and postmarket regulatory framework.

The Changing Economics of Medical Technology

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Publisher : National Academies Press
ISBN 13 : 030904491X
Total Pages : 225 pages
Book Rating : 4.3/5 (9 download)

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Book Synopsis The Changing Economics of Medical Technology by : Institute of Medicine

Download or read book The Changing Economics of Medical Technology written by Institute of Medicine and published by National Academies Press. This book was released on 1991-02-01 with total page 225 pages. Available in PDF, EPUB and Kindle. Book excerpt: Americans praise medical technology for saving lives and improving health. Yet, new technology is often cited as a key factor in skyrocketing medical costs. This volume, second in the Medical Innovation at the Crossroads series, examines how economic incentives for innovation are changing and what that means for the future of health care. Up-to-date with a wide variety of examples and case studies, this book explores how payment, patent, and regulatory policiesâ€"as well as the involvement of numerous government agenciesâ€"affect the introduction and use of new pharmaceuticals, medical devices, and surgical procedures. The volume also includes detailed comparisons of policies and patterns of technological innovation in Western Europe and Japan. This fact-filled and practical book will be of interest to economists, policymakers, health administrators, health care practitioners, and the concerned public.

Public Health Effectiveness of the FDA 510(k) Clearance Process

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Author :
Publisher : National Academies Press
ISBN 13 : 0309162904
Total Pages : 141 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Public Health Effectiveness of the FDA 510(k) Clearance Process by : Institute of Medicine

Download or read book Public Health Effectiveness of the FDA 510(k) Clearance Process written by Institute of Medicine and published by National Academies Press. This book was released on 2010-10-04 with total page 141 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Food and Drug Administration (FDA) is responsible for assuring that medical devices are safe and effective before they go on the market. As part of its assessment of FDA's premarket clearance process for medical devices, the IOM held a workshop June 14-15 to discuss how to best balance patient safety and technological innovation. This document summarizes the workshop.

Advances in Patient Safety

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Author :
Publisher :
ISBN 13 :
Total Pages : 526 pages
Book Rating : 4.7/5 (54 download)

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Book Synopsis Advances in Patient Safety by : Kerm Henriksen

Download or read book Advances in Patient Safety written by Kerm Henriksen and published by . This book was released on 2005 with total page 526 pages. Available in PDF, EPUB and Kindle. Book excerpt: v. 1. Research findings -- v. 2. Concepts and methodology -- v. 3. Implementation issues -- v. 4. Programs, tools and products.

Drug Abuse and Addiction in Medical Illness

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Publisher : Springer Science & Business Media
ISBN 13 : 1461433754
Total Pages : 569 pages
Book Rating : 4.4/5 (614 download)

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Book Synopsis Drug Abuse and Addiction in Medical Illness by : Joris C. Verster

Download or read book Drug Abuse and Addiction in Medical Illness written by Joris C. Verster and published by Springer Science & Business Media. This book was released on 2012-07-06 with total page 569 pages. Available in PDF, EPUB and Kindle. Book excerpt: Drug abuse and addiction are common in clinical practice. Often they interfere with patient treatment or require an alternative approach. Drug Abuse and Addiction in Medical Illness: Causes, Consequences, and Treatment is a major contribution to the literature, a gold standard title offering a comprehensive range of topics for those who care for patients with addiction, conduct research in this area, or simply have an interest in the field. Offering state-of-the-art information for all those working with drug abusing or addicted patients, or for those interested in this topic from other research perspectives, the volume is a first of its kind book -- rich, comprehensive, yet focused, addressing the needs of the very active theoretical, basic, and clinical research in the field. Comprised of 46 chapters organized in four sections and developed by the leading international experts, Drug Abuse and Addiction in Medical Illness: Causes, Consequences, and Treatment covers virtually every core, as well as contemporary, topic on addiction, from the established theories to the most modern research and development in the field. Enhancing the educational value of the volume, every chapter includes an abstract and two boxes summarizing learning objectives and directions for future research. Drug Abuse and Addiction in Medical Illness: Causes, Consequences, and Treatment discusses the topic in a authoritative, systematic manner and is an indispensable reference for all clinicians and researchers interested in this rapidly changing field.

The Danger Within Us

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Publisher : Little, Brown
ISBN 13 : 0316343781
Total Pages : 306 pages
Book Rating : 4.3/5 (163 download)

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Book Synopsis The Danger Within Us by : Jeanne Lenzer

Download or read book The Danger Within Us written by Jeanne Lenzer and published by Little, Brown. This book was released on 2017-12-12 with total page 306 pages. Available in PDF, EPUB and Kindle. Book excerpt: Did you know... Medical interventions have become the third leading cause of death in America. An estimated 10 percent of Americans are implanted with medical devices -- like pacemakers, artificial hips, cardiac stents, etc. The overwhelming majority of high-risk implanted devices have never undergone a single clinical trial. In The Danger Within Us, award-winning journalist Jeanne Lenzer brings these horrifying statistics to life through the story of one working class man who, after his "cure" nearly kills him, ends up in a battle for justice against the medical establishment. His crusade leads Lenzer on a journey through the dark underbelly of the medical device industry, a fascinating and disturbing world that hasn't been written about before. What Lenzer exposes will shock readers: rampant corruption, elaborate cover-ups, shameless profiteering, and astonishing lack of oversight, all of which leads to dangerous devices (from artificial hips to pacemakers) going to market and into our bodies. In the vein of America's Bitter Pill and A Civil Action, The Danger Within Us is a stirring call for reform and a must-read for anyone who cares about the future of American healthcare. "Before you get anything implanted in your body, read this book."-Shannon Brownlee, author of Overtreated

Drug and Medical Device Product Liability Deskbook

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Author :
Publisher : Law Journal Press
ISBN 13 : 9781588521217
Total Pages : 982 pages
Book Rating : 4.5/5 (212 download)

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Book Synopsis Drug and Medical Device Product Liability Deskbook by : James Beck

Download or read book Drug and Medical Device Product Liability Deskbook written by James Beck and published by Law Journal Press. This book was released on 2004 with total page 982 pages. Available in PDF, EPUB and Kindle. Book excerpt: This timely guide covers all aspects of litigation involving drugs, medical devices, vaccines and other FDA-regulated prescription products.

Conflict of Interest in Medical Research, Education, and Practice

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Author :
Publisher : National Academies Press
ISBN 13 : 0309145449
Total Pages : 436 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Conflict of Interest in Medical Research, Education, and Practice by : Institute of Medicine

Download or read book Conflict of Interest in Medical Research, Education, and Practice written by Institute of Medicine and published by National Academies Press. This book was released on 2009-09-16 with total page 436 pages. Available in PDF, EPUB and Kindle. Book excerpt: Collaborations of physicians and researchers with industry can provide valuable benefits to society, particularly in the translation of basic scientific discoveries to new therapies and products. Recent reports and news stories have, however, documented disturbing examples of relationships and practices that put at risk the integrity of medical research, the objectivity of professional education, the quality of patient care, the soundness of clinical practice guidelines, and the public's trust in medicine. Conflict of Interest in Medical Research, Education, and Practice provides a comprehensive look at conflict of interest in medicine. It offers principles to inform the design of policies to identify, limit, and manage conflicts of interest without damaging constructive collaboration with industry. It calls for both short-term actions and long-term commitments by institutions and individuals, including leaders of academic medical centers, professional societies, patient advocacy groups, government agencies, and drug, device, and pharmaceutical companies. Failure of the medical community to take convincing action on conflicts of interest invites additional legislative or regulatory measures that may be overly broad or unduly burdensome. Conflict of Interest in Medical Research, Education, and Practice makes several recommendations for strengthening conflict of interest policies and curbing relationships that create risks with little benefit. The book will serve as an invaluable resource for individuals and organizations committed to high ethical standards in all realms of medicine.

Medical Devices and Drug Issues

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Author :
Publisher :
ISBN 13 :
Total Pages : 412 pages
Book Rating : 4.F/5 ( download)

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Book Synopsis Medical Devices and Drug Issues by : United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health and the Environment

Download or read book Medical Devices and Drug Issues written by United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health and the Environment and published by . This book was released on 1987 with total page 412 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Facing Addiction in America

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Author :
Publisher : Createspace Independent Publishing Platform
ISBN 13 : 9781974580620
Total Pages : 420 pages
Book Rating : 4.5/5 (86 download)

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Book Synopsis Facing Addiction in America by : Office of the Surgeon General

Download or read book Facing Addiction in America written by Office of the Surgeon General and published by Createspace Independent Publishing Platform. This book was released on 2017-08-15 with total page 420 pages. Available in PDF, EPUB and Kindle. Book excerpt: All across the United States, individuals, families, communities, and health care systems are struggling to cope with substance use, misuse, and substance use disorders. Substance misuse and substance use disorders have devastating effects, disrupt the future plans of too many young people, and all too often, end lives prematurely and tragically. Substance misuse is a major public health challenge and a priority for our nation to address. The effects of substance use are cumulative and costly for our society, placing burdens on workplaces, the health care system, families, states, and communities. The Report discusses opportunities to bring substance use disorder treatment and mainstream health care systems into alignment so that they can address a person's overall health, rather than a substance misuse or a physical health condition alone or in isolation. It also provides suggestions and recommendations for action that everyone-individuals, families, community leaders, law enforcement, health care professionals, policymakers, and researchers-can take to prevent substance misuse and reduce its consequences.

Drug Safety

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Author :
Publisher :
ISBN 13 :
Total Pages : 12 pages
Book Rating : 4.:/5 (7 download)

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Book Synopsis Drug Safety by : United States. General Accounting Office

Download or read book Drug Safety written by United States. General Accounting Office and published by . This book was released on 2001 with total page 12 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Medical Devices

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Publisher : World Health Organization
ISBN 13 : 9241564040
Total Pages : 147 pages
Book Rating : 4.2/5 (415 download)

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Book Synopsis Medical Devices by : World Health Organization

Download or read book Medical Devices written by World Health Organization and published by World Health Organization. This book was released on 2010 with total page 147 pages. Available in PDF, EPUB and Kindle. Book excerpt: Background papers 1 to 9 published as technical documents. Available in separate records from WHO/HSS/EHT/DIM/10.1 to WHO/HSS/EHT/DIM/10.9

Emerging Nanotechnologies for Diagnostics, Drug Delivery and Medical Devices

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Author :
Publisher : William Andrew
ISBN 13 : 0323429971
Total Pages : 418 pages
Book Rating : 4.3/5 (234 download)

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Book Synopsis Emerging Nanotechnologies for Diagnostics, Drug Delivery and Medical Devices by : Ashim K Mitra

Download or read book Emerging Nanotechnologies for Diagnostics, Drug Delivery and Medical Devices written by Ashim K Mitra and published by William Andrew. This book was released on 2017-02-13 with total page 418 pages. Available in PDF, EPUB and Kindle. Book excerpt: Emerging Nanotechnologies for Diagnostics, Drug Delivery and Medical Devices covers the modern micro and nanotechnologies used for diagnosis, drug delivery, and theranostics using micro, nano, and implantable systems. In-depth coverage of all aspects of disease treatment is included. In addition, the book covers cutting-edge research and technology that will help readers gain knowledge of novel approaches and their applications to improve drug/agent specificity for diagnosis and efficient disease treatment. It is a comprehensive guide for medical specialists, the pharmaceutical-industry, and academic researchers discussing the impact of nanotechnology on diagnosis, drug delivery, and theranostics. - Gives readers working in immunology, drug delivery, and medicine a greater awareness on how novel nanotechnology orientated methods can help improve treatment - Provides readers with backgrounds in nanotechnology, chemistry, and materials science an understanding on how nanotechnology is used in immunology and drug delivery - Includes focused coverage of the use of nanodevices in diagnostics, therapeutics, and theranostics not offered by other books