Download or read book Should FDA Drug and Medical Device Regulation Bar State Liability Claims written by United States. Congress. House. Committee on Oversight and Government Reform and published by . This book was released on 2010 with total page 228 pages. Available in PDF, EPUB and Kindle. Book excerpt:
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.
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.
Download or read book Dietary Supplements written by United States. Federal Trade Commission. Bureau of Consumer Protection and published by . This book was released on 1998 with total page 32 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Preemption Choice written by William W. Buzbee and published by Cambridge University Press. This book was released on 2008-12-15 with total page 337 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book examines the theory, law, and reality of preemption choice. The Constitution's federalist structures protect states' sovereignty but also create a powerful federal government that can preempt and thereby displace the authority of state and local governments and courts to respond to a social challenge. Despite this preemptive power, Congress and agencies have seldom preempted state power. Instead, they typically have embraced concurrent, overlapping power. Recent legislative, agency, and court actions, however, reveal an aggressive use of federal preemption, sometimes even preempting more protective state law. Preemption choice fundamentally involves issues of institutional choice and regulatory design: should federal actors displace or work in conjunction with other legal institutions? This book moves logically through each preemption choice step, ranging from underlying theory to constitutional history, to preemption doctrine, to assessment of when preemptive regimes make sense and when state regulation and common law should retain latitude for dynamism and innovation.
Download or read book H R 1346 the Medical Device Safety Act of 2009 written by United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health and published by . This book was released on 2011 with total page 152 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Laws of Medicine written by Amirala S. Pasha and published by Springer Nature. This book was released on 2022-09-07 with total page 548 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides an overview of the US laws that affect clinical practice for healthcare professionals with no legal background. Divided into thirteen sections, each chapter starts with a summary of the chapter’s content and relevant legal concepts in bullet points before discussing the topics in detail. An application section is provided in many chapters to clarify essential issues by reflecting on clinically relevant case law or clinical vignette(s). Filling a crucial gap in the literature, this comprehensive guide gives healthcare professionals an understanding or a starting point to legal aspects of healthcare.
Download or read book Activities of the Committee on Oversight and Government Reform January 2 2009 110 2 House Report 110 930 written by and published by . This book was released on 2009 with total page 156 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book A Ctivities of the Committee on Oversight and Government Reform January 2 2009 110 2 House Report 110 930 written by and published by . This book was released on 2009 with total page 156 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Developing New Contraceptives written by National Research Council and Institute of Medicine and published by National Academies Press. This book was released on 1990-01-01 with total page 206 pages. Available in PDF, EPUB and Kindle. Book excerpt: There are numerous reasons to hasten the introduction of new and improved contraceptivesâ€"from health concerns about the pill to the continuing medical liability crisis. Yet, U.S. organizations are far from taking a leadership position in funding, researching, and introducing new contraceptivesâ€"in fact, the United States lags behind Europe and even some developing countries in this field. Why is research and development of contraceptives stagnating? What must the nation do to energize this critical arena? This book presents an overall examination of contraceptive development in the United Statesâ€"covering research, funding, regulation, product liability, and the effect of public opinion. The distinguished authoring committee presents a blueprint for substantial change, with specific policy recommendations that promise to gain the attention of specialists, the media, and the American public. The highly readable and well-organized volume will quickly become basic reading for legislators, government agencies, the pharmaceutical industry, private organizations, legal professionals, and researchersâ€"everyone concerned about family planning, reproductive health, and the impact of the liability and regulatory systems on scientific innovations.
Download or read book Legislative Calendar written by United States. Congress. House. Committee on Government Operations and published by . This book was released on 2007 with total page 952 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Legislative Calendar written by United States. Congress. House. Committee on Government Reform and published by . This book was released on 2008 with total page 952 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Legislative Calendar written by United States. Congress. House. Committee on Oversight and Government Reform and published by . This book was released on 2008 with total page 952 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book An Overview of FDA Regulated Products written by Eunjoo Pacifici and published by Academic Press. This book was released on 2018-06-13 with total page 280 pages. Available in PDF, EPUB and Kindle. Book excerpt: Today’s challenge, especially for many newcomers to the regulated industry, is not necessarily to gather regulatory information, but to know how to interpret and apply it. The ability to discern what is important from what is not, and to interpret regulatory documents correctly, provides a valuable competitive advantage to any newcomer or established professional in this field. An Overview of FDA Regulated Products: From Drugs and Medical Devices to Food and Tobacco provides a valuable summary of the key information to unveil the meaning of critical, and often complex, regulatory concepts. Concise and easy to read with practical explanations, key points, summaries and case studies, this book highlights the regulatory processes involved in bringing an FDA regulated product from research and development to approval and market. Although the primary focus will be on the US system, this book also features global perspectives where appropriate. A valuable resource for students, professors and professionals, An Overview of FDA Regulated Products illustrates the most important elements and concepts so that the reader can focus on the critical issues and make the necessary connections to be successful. Provides an overview of key regulatory requirements using a practical approach that features detailed discussions of hypothetical and real-world case studies in order to highlight the concepts and applications of regulations Covers all FDA regulated products, including drugs, biologics, medical devices, cosmetics, foods, dietary supplements, cosmetics, veterinary products, tobacco and more in one single reference Illustrates complex topics in a clear, succinct and engaging manner by breaking down technical terms and offering straightforward and easy to understand explanations
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 2011-10-25 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.
Download or read book Congressional Record written by United States. Congress and published by . This book was released on 2008 with total page 712 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Congressional Record is the official record of the proceedings and debates of the United States Congress. It is published daily when Congress is in session. The Congressional Record began publication in 1873. Debates for sessions prior to 1873 are recorded in The Debates and Proceedings in the Congress of the United States (1789-1824), the Register of Debates in Congress (1824-1837), and the Congressional Globe (1833-1873)
Download or read book Congressional Record Daily Digest of the Congress written by United States. Congress and published by . This book was released on 2008 with total page 712 pages. Available in PDF, EPUB and Kindle. Book excerpt:
