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Author: Nupur Chowdhury
Publisher: Springer
ISBN: 9783319353210
Category : Law
Languages : en
Pages : 0
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Book Description
One of the primary functions of law is to ensure that the legal structure governing all social relations is predictable, coherent, consistent and applicable. Taken together, these characteristics of law are referred to as legal certainty. In traditional approaches to legal certainty, law is regarded as a hierarchical system of rules characterized by stability, clarity, uniformity, calculable enforcement, publicity and predictability. However, the current reality is that national legal systems no longer operate in isolation, but within a multilevel legal order, wherein norms created at both the international and regional level are directly applicable to national legal systems. Also, norm creation is no longer the exclusive prerogative of public officials of the state: private actors have an increasing influence on norm creation as well. Social scientists have referred to this phenomenon of interacting and overlapping competences as multilevel governance. Only recently have legal scholars focused attention on the increasing interconnectedness (and therefore the concomitant loss of primacy of national legal orders) between the global, European and national regulatory spheres through the concept of multilevel regulation. In this project the author uses multilevel regulation as a term to characterize a regulatory space in which the process of rule making, rule enforcement and rule adjudication (the regulatory lifecycle) is dispersed across more than one administrative or territorial level and amongst several different actors, both public and private. The author draws on the concept of a regulatory space, using it as a framing device to differentiate between specific aspects of policy fields. The relationship between actors in such a space is non-hierarchical and they may be independent of each other. The lack of central ordering of the regulatory lifecycle within this regulatory space is the most important feature of such a space. The implications of multilevel regulation for the notion of legal certainty have attracted limited attention from scholars and the demand for legal certainty in regulatory practice is still a puzzle. The book explores the idea of legal certainty in terms of the perceptions and expectations of regulatees in the context of medical products – specifically, pharmaceuticals and medical devices, which can be differentiated as two regulatory spaces and therefore form two case studies. As an exploratory project, the book necessarily explores new territory in terms of investigating legal certainty first in terms of regulatee perceptions and expectations and second, because it studies it in the context of multilevel regulation.
Author: Nupur Chowdhury
Publisher: Springer
ISBN: 9783319353210
Category : Law
Languages : en
Pages : 0
Get Book Here
Book Description
One of the primary functions of law is to ensure that the legal structure governing all social relations is predictable, coherent, consistent and applicable. Taken together, these characteristics of law are referred to as legal certainty. In traditional approaches to legal certainty, law is regarded as a hierarchical system of rules characterized by stability, clarity, uniformity, calculable enforcement, publicity and predictability. However, the current reality is that national legal systems no longer operate in isolation, but within a multilevel legal order, wherein norms created at both the international and regional level are directly applicable to national legal systems. Also, norm creation is no longer the exclusive prerogative of public officials of the state: private actors have an increasing influence on norm creation as well. Social scientists have referred to this phenomenon of interacting and overlapping competences as multilevel governance. Only recently have legal scholars focused attention on the increasing interconnectedness (and therefore the concomitant loss of primacy of national legal orders) between the global, European and national regulatory spheres through the concept of multilevel regulation. In this project the author uses multilevel regulation as a term to characterize a regulatory space in which the process of rule making, rule enforcement and rule adjudication (the regulatory lifecycle) is dispersed across more than one administrative or territorial level and amongst several different actors, both public and private. The author draws on the concept of a regulatory space, using it as a framing device to differentiate between specific aspects of policy fields. The relationship between actors in such a space is non-hierarchical and they may be independent of each other. The lack of central ordering of the regulatory lifecycle within this regulatory space is the most important feature of such a space. The implications of multilevel regulation for the notion of legal certainty have attracted limited attention from scholars and the demand for legal certainty in regulatory practice is still a puzzle. The book explores the idea of legal certainty in terms of the perceptions and expectations of regulatees in the context of medical products – specifically, pharmaceuticals and medical devices, which can be differentiated as two regulatory spaces and therefore form two case studies. As an exploratory project, the book necessarily explores new territory in terms of investigating legal certainty first in terms of regulatee perceptions and expectations and second, because it studies it in the context of multilevel regulation.
Author: Nupur Chowdhury
Publisher: Springer
ISBN: 9783319045955
Category : Law
Languages : en
Pages : 185
Get Book Here
Book Description
One of the primary functions of law is to ensure that the legal structure governing all social relations is predictable, coherent, consistent and applicable. Taken together, these characteristics of law are referred to as legal certainty. In traditional approaches to legal certainty, law is regarded as a hierarchical system of rules characterized by stability, clarity, uniformity, calculable enforcement, publicity and predictability. However, the current reality is that national legal systems no longer operate in isolation, but within a multilevel legal order, wherein norms created at both the international and regional level are directly applicable to national legal systems. Also, norm creation is no longer the exclusive prerogative of public officials of the state: private actors have an increasing influence on norm creation as well. Social scientists have referred to this phenomenon of interacting and overlapping competences as multilevel governance. Only recently have legal scholars focused attention on the increasing interconnectedness (and therefore the concomitant loss of primacy of national legal orders) between the global, European and national regulatory spheres through the concept of multilevel regulation. In this project the author uses multilevel regulation as a term to characterize a regulatory space in which the process of rule making, rule enforcement and rule adjudication (the regulatory lifecycle) is dispersed across more than one administrative or territorial level and amongst several different actors, both public and private. The author draws on the concept of a regulatory space, using it as a framing device to differentiate between specific aspects of policy fields. The relationship between actors in such a space is non-hierarchical and they may be independent of each other. The lack of central ordering of the regulatory lifecycle within this regulatory space is the most important feature of such a space. The implications of multilevel regulation for the notion of legal certainty have attracted limited attention from scholars and the demand for legal certainty in regulatory practice is still a puzzle. The book explores the idea of legal certainty in terms of the perceptions and expectations of regulatees in the context of medical products – specifically, pharmaceuticals and medical devices, which can be differentiated as two regulatory spaces and therefore form two case studies. As an exploratory project, the book necessarily explores new territory in terms of investigating legal certainty first in terms of regulatee perceptions and expectations and second, because it studies it in the context of multilevel regulation.
Author: I. Glenn Cohen
Publisher: Cambridge University Press
ISBN: 1108838634
Category : Law
Languages : en
Pages : 295
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Book Description
A detailed analysis of the ethical, legal, and regulatory landscape of medical devices in the US and EU.
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309162904
Category : Medical
Languages : en
Pages : 141
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Book Description
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.
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309212421
Category : Medical
Languages : en
Pages : 318
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Book Description
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.
Author: Michael Cheng
Publisher: World Health Organization
ISBN: 9241546182
Category : Medical
Languages : en
Pages : 54
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Book Description
The term 'medical devices' covers a wide range of equipment essential for patient care at every level of the health service, whether at the bedside, at a health clinic or in a large specialised hospital. Yet many countries lack access to high-quality devices, particularly in developing countries where health technology assessments are rare and there is a lack of regulatory controls to prevent the use of substandard devices. This publication provides a guidance framework for countries wishing to create or modify their own regulatory systems for medical devices, based on best practice experience in other countries. Issues highlighted include: the need for harmonised regulations; and the adoption, where appropriate, of device approvals of advanced regulatory systems to avoid an unnecessary drain on scarce resources. These approaches allow emphasis to be placed on locally-assessed needs, including vendor and device registration, training and surveillance and information exchange systems.
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 030904491X
Category : Medical
Languages : en
Pages : 225
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Book Description
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.
Author: OECD
Publisher: OECD Publishing
ISBN: 9264805907
Category :
Languages : en
Pages : 447
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Book Description
This volume, developed by the Observatory together with OECD, provides an overall conceptual framework for understanding and applying strategies aimed at improving quality of care. Crucially, it summarizes available evidence on different quality strategies and provides recommendations for their implementation. This book is intended to help policy-makers to understand concepts of quality and to support them to evaluate single strategies and combinations of strategies.
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309042860
Category : Medical
Languages : en
Pages : 241
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Book Description
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.
Author: John J. Tobin
Publisher: John Wiley & Sons
ISBN: 3527644717
Category : Science
Languages : en
Pages : 304
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Book Description
Written in a clear and concise style by an experienced author, this attractively-priced book covers regulatory affairs in all major global markets for pharmaceuticals and medical devices, making it the most comprehensive in its field. Following a look at drug development, complete sections are devoted to national and EU regulatory issues, manufacturing license application and retention, and regulation in the USA. Other topics dealt with include CDER, CBER and marketing and manufacturing licenses, the ICH process and Good Laboratory/Clinical/Manufacturing Practices. Everything pharmacologists, bioengineers, pharma engineers, students in pharmacy and those working in the pharmaceutical industry need to know about medical regulatory affairs.
