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 Guide to the Implementation of Directives Based on the New Approach and the Global Approach written by European Commission and published by . This book was released on 2000 with total page 124 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book A review of UK health research funding written by David Sir Cooksey and published by The Stationery Office. This book was released on 2006-12-06 with total page 132 pages. Available in PDF, EPUB and Kindle. Book excerpt: This Review sets out to propose a structure for the funding arrangements for the whole spectrum of health research, with the objective of obtaining the maximum benefit from research success and, where possible, eliminating duplication of effort. The Review found, however, that the UK is at risk of failing to reap the full economic, health and social benefits that the UK's public investment in health research should generate. There is no overarching UK health research strategy to ensure UK health priorities are considered through all types of research and there are two key gaps in the translation of health research: (i) translating ideas from basic and clinical research into the development of new products and approaches to treatment of disease and illness; (ii) implementing those new products and approaches into clinical practice.The Review also found that the wider funding arrangements for supporting translation of ideas from conception to practice could be more coherent or comprehensive and, where arrangements exist, they do not function well. The Review identified cultural, institutional and financial barriers to translating research into practice in the publicly funded research arena. But it also found that, in the private sector, the pharmaceuticals industry is facing increasing challenges in translating research into health and economic benefit. The Review has sought to make recommendations that will increase the translation of R&D into health and economic benefit for the UK, both in the public and private sectors. The Review recommends that the Government should seek to achieve better coordination of health research and more coherent funding arrangements to support translation by establishing an Office for Strategic Coordination of Health Research (OSCHR).
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.
Download or read book Europe Now written by and published by . This book was released on 1991 with total page 86 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book National Trade Estimate Report on Foreign Trade Barriers written by United States. Office of the U.S. Trade Representative and published by . This book was released on 1997 with total page 408 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Business America written by and published by . This book was released on 1994 with total page 630 pages. Available in PDF, EPUB and Kindle. Book excerpt: Includes articles on international business opportunities.
Download or read book Alternatives to Animal Experiments written by David Henry Smyth and published by . This book was released on 1978 with total page 228 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book The Rules of Federalism written by R. Daniel. KELEMEN and published by Harvard University Press. This book was released on 2009-06-30 with total page 257 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book examines patterns of environmental regulation in the European Union and four federal polities--the United States, Germany, Australia, and Canada. Daniel Kelemen develops a theory of regulatory federalism based on his comparative study, arguing that the greater the fragmentation of power at the federal level, the less discretion is allotted to component states. Kelemen's analysis offers a novel perspective on the EU and demonstrates that the EU already acts as a federal polity in the regulatory arena. In The Rules of Federalism, Kelemen shows that both the structure of the EU's institutions and the control these institutions exert over member states closely resemble the American federal system, with its separation of powers, large number of veto points, and highly detailed, judicially enforceable legislation. In the EU, as in the United States, a high degree of fragmentation in the central government yields a low degree of discretion for member states when it comes to implementing regulatory statutes. Table of Contents: Acknowledgments 1. Regulatory Federalism and the EU 2. Environmental Regulation in the EU 3. Environmental Regulation in the United States 4. Environmental Regulation in Germany 5. Environmental Regulation in Australia and Canada 6. Food and Drug Safety Regulation in the EU 7. Institutional Structure and Regulatory Style Notes References Cases Cited Index R. Daniel Kelemen's The Rules of Federalism is an important contribution to both the literature on federalism and on the European Union. It makes an original theoretical and empirical contribution to our understanding of regulatory federalism and sheds new light on the federal systems which it compares. It will open up new avenues of inquiry. --Alberta Sbragia, University of Pittsburgh The Rules of Federalism makes a significant contribution to the literature on regulatory federalism. Keleman's original theoretical perspective is made plausible through a series of fascinating case studies. The book will be of interest to scholars of federalism, constitutional design, environmental policy, and the European Union. --Susan Rose-Ackerman, Yale Law School
Download or read book Airworthiness written by Filippo De Florio and published by Butterworth-Heinemann. This book was released on 2016-07-12 with total page 554 pages. Available in PDF, EPUB and Kindle. Book excerpt: Airworthiness: An Introduction to Aircraft Certification and Operations, Third Edition, once again proves to be a valuable, user-friendly reference guide for certification engineers engaged in professional training and practical work in regulatory agencies and aircraft engineering companies. The discussions reflect the recent changes in the EASA-FAA regulations and also include the concepts of flight safety and airworthiness; the ICAO and civil aviation authorities; airworthiness requirements; type certifications and the type-certification process; production of products, parts, and appliances; certifications of airworthiness; and rules for spaceworthiness. Since publication of the second edition, airworthiness regulation and certification around the world have gone through significant changes. For example, EASA structure has completely changed, FAA rules are no longer applicable, substantial changes have been made in the international airworthiness regulations and certification procedures, and unmanned aircraft have evolved technically and operationally. The changes in airworthiness regulations in the last five years have been striking, changing the way in which we look at airworthiness and certification processes around the world. - Includes updates throughout to reflect changes to the airworthiness regulations of the two most influential ruling authorities—EASA and FAA - Includes an update on remotely piloted air systems as well as space vehicles - Provides guidelines to shape a comprehensive 'certification map' including comparisons, explanations, and backgrounds of institutions and processes - Features a new chapter "Certificates of Airworthiness and Permits to Fly" that provides an overall description of the requirements governing the certificates of airworthiness
Download or read book Implications of the EC 1992 Plan for U S Trade Competitiveness and Small Business written by United States. Congress. House. Committee on Small Business and published by . This book was released on 1989 with total page 208 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Regulatory Encounters written by Lee Axelrad and published by Univ of California Press. This book was released on 2000-10-02 with total page 452 pages. Available in PDF, EPUB and Kindle. Book excerpt: "This is a pathbreaking contribution to a much neglected area of academic study."—Bridget M. Hutter, London School of Economics "Regulatory Encounters is an extremely impressive book that contains rich, varied, and convincing case studies on an important topic, American 'adversarial legalism.'"—R. Shep Melnick, Boston College
Download or read book The EBMT EHA CAR T Cell Handbook written by Nicolaus Kröger and published by Springer Nature. This book was released on 2022-02-07 with total page 221 pages. Available in PDF, EPUB and Kindle. Book excerpt: This first open access European CAR-T Handbook, co-promoted by the European Society for Blood and Marrow Transplantation (EBMT) and the European Hematology Association (EHA), covers several aspects of CAR-T cell treatments, including the underlying biology, indications, management of side-effects, access and manufacturing issues. This book, written by leading experts in the field to enhance readers’ knowledge and practice skills, provides an unparalleled overview of the CAR-T cell technology and its application in clinical care, to enhance readers’ knowledge and practice skills.
Download or read book Guideline on General Principles of Process Validation written by and published by . This book was released on 1987 with total page 32 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Dosage Forms Formulation Developments and Regulations written by Amit Kumar Nayak and published by Elsevier. This book was released on 2023-12-09 with total page 759 pages. Available in PDF, EPUB and Kindle. Book excerpt: Dosage Forms, Formulation Developments and Regulations, Volume One in the Recent and Future Trends in Pharmaceutics series, explores aspects of pharmaceutics, with an original approach focused on technology, novelties and future trends in the field. The book discusses the most recent developments in pharmaceutical preformulation and formulation studies, biopharmaceutics and novel pharmaceutical formulations, regulatory affairs, and good manufacturing practices. Exciting areas such as formulation strategies, optimization techniques, the biopharmaceutical classification system, and pharmaceutical aerosols are included. The field of pharmaceutics is highly dynamic and rapidly expanding day-by-day, so it demands a variety of amplified efforts for designing and developing pharmaceutical processes and formulation strategies. This is an essential reference for researchers in academia and industry as well as advanced graduate students in pharmaceutics. - Examines trends and recent technologies in dosage, formulation and regulation - Contains contributions from leading experts in academia, research, industry and regulatory agencies - Includes high-quality illustrations, flow charts and tables for easy understanding of concepts - Discusses practical examples and research case studies
Download or read book Pharmaceutical Biotechnology and Chemical Inventions written by Duncan Geoffrey Bucknell and published by Oxford University Press, USA. This book was released on 2011 with total page 2534 pages. Available in PDF, EPUB and Kindle. Book excerpt: Focuses on: Australia, Canada, China, India, Japan, the United States, Europe, France, Germany, Italy, the Netherlands, and the United Kingdom.
Download or read book Medical Product Regulatory Affairs written by John J. Tobin and published by John Wiley & Sons. This book was released on 2023-12-04 with total page 341 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical Product Regulatory Affairs Hands-on guide through the jungle of medical regulatory affairs for every professional involved in bringing new products to market Based on a module prepared by the authors for an MSc course offered by the University of Limerick, Ireland, Medical Product Regulatory Affairs is a comprehensive and practical guide on how pharmaceutical and medical devices are regulated within the major global markets. The Second Edition builds on the success of the first with an even wider scope and full coverage of new EU regulations on the safe use of medical devices. 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. Medical Product Regulatory Affairs includes information on: Aims and structure of regulation, covering purpose and principles of regulation, national and EU legislative processes, and pharmacopeia Regulatory strategy, covering product development and manufacturing, market vigilance, quality assurance systems, personnel, and documentation Drug discovery and development, covering prescription status, physical properties, therapeutic use, and drug discovery, development, and delivery Non-clinical studies, covering non-clinical study objectives and timing, pharmacological and pharmacodynamic studies, and bioavailability and bioequivalence Clinical trials, covering trial protocol, monitoring of trials, trial master files, and FDA communications The wide coverage of different product types and the main global markets makes Medical Product Regulatory Affairs ideal for training courses on regulatory affairs in academia and industry. It is also a valuable reference for pharmacologists, bioengineers, pharma engineers, and students in pharmacy to familiarize themselves with the topic.
