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Author: National Academies of Sciences, Engineering, and Medicine Publisher: National Academies Press ISBN: 0309498635 Category : Medical Languages : en Pages : 169
Book Description
Globalization is rapidly changing lives and industries around the world. Drug development, authorization, and regulatory supervision have become international endeavors, with most medicines becoming global commodities. Drug companies utilize global supply chains that often include facilities in countries with inconsistent regulations from those of the United States, perform pivotal trials in multiple countries to support registration submissions in various jurisdictions, and subsequently market their medicines throughout most of the world. These companies operate across borders and require individual national regulators to ensure that drugs authorized for use in their countries are safe and effective, and appropriate for their health care system and their population. This process involves significant resources and often duplicative work. It is important to consider how this process can be improved in order to better allocate resources, time, and efforts to improve public health. Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators considers the role of mutual recognition and other reliance activities among regulators in contributing to enhancing public health. This report identifies opportunities for leveraging reliance activities more broadly in order to potentially impact public health globally. Key topics in this report include the job of medicines regulators in today's world, what policy makers need to know about today's regulatory environment, stakeholder views of recognition and reliance, as well as removing impediments and facilitating action for greater recognition and reliance among regulatory authorities.
Author: National Academies of Sciences, Engineering, and Medicine Publisher: National Academies Press ISBN: 0309498635 Category : Medical Languages : en Pages : 169
Book Description
Globalization is rapidly changing lives and industries around the world. Drug development, authorization, and regulatory supervision have become international endeavors, with most medicines becoming global commodities. Drug companies utilize global supply chains that often include facilities in countries with inconsistent regulations from those of the United States, perform pivotal trials in multiple countries to support registration submissions in various jurisdictions, and subsequently market their medicines throughout most of the world. These companies operate across borders and require individual national regulators to ensure that drugs authorized for use in their countries are safe and effective, and appropriate for their health care system and their population. This process involves significant resources and often duplicative work. It is important to consider how this process can be improved in order to better allocate resources, time, and efforts to improve public health. Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators considers the role of mutual recognition and other reliance activities among regulators in contributing to enhancing public health. This report identifies opportunities for leveraging reliance activities more broadly in order to potentially impact public health globally. Key topics in this report include the job of medicines regulators in today's world, what policy makers need to know about today's regulatory environment, stakeholder views of recognition and reliance, as well as removing impediments and facilitating action for greater recognition and reliance among regulatory authorities.
Author: Sam F Halabi Publisher: Academic Press ISBN: 0128025506 Category : Technology & Engineering Languages : en Pages : 258
Book Description
Food and Drug Regulation in an Era of Globalized Markets provides a synthesized look at the pressures that are impacting today's markets, including trade liberalization, harmonization initiatives between governments, increased aid activities to low-and middle-income countries, and developing pharmaceutical sectors in China and India. From the changing nature of packaged and processed food supply chains, to the reorientation of pharmaceutical research and funding coalesced to confront firms, regulators, and consumers are now faced with previously unknown challenges. Based on the 2014 O'Neill Institute Summer program, this book provides an international, cross-disciplinary look at the changing world of regulations and offers insights into requirements for successful implementation. - Interdisciplinary approach allows readers to understand the varying perspectives involved in regulatory development - Includes case studies to highlight harmonization efforts and challenges, and to provide practical insights for application going forward - Provides a thorough assessment of supply chains, potential gaps, and means of anticipating and addressing issues - Presents a comprehensive snapshot of changes in the food safety law in the United States and under international standards, including academic, industry and regulatory perspectives - Addresses conflicts and cooperation between relevant US agencies including USDA, FDA, DEA, EPA, FTC and the Department of Commerce
Author: Holly Fernandez Lynch Publisher: Columbia University Press ISBN: 0231540078 Category : Business & Economics Languages : en Pages : 499
Book Description
In its decades-long effort to assure the safety, efficacy, and security of medicines and other products, the Food and Drug Administration has struggled with issues of funding, proper associations with industry, and the balance between consumer choice and consumer protection. Today, these challenges are compounded by the pressures of globalization, the introduction of novel technologies, and fast-evolving threats to public health. With essays by leading scholars and government and private-industry experts, FDA in the Twenty-First Century addresses perennial and new problems and the improvements the agency can make to better serve the public good. The collection features essays on effective regulation in an era of globalization, consumer empowerment, and comparative effectiveness, as well as questions of data transparency, conflicts of interest, industry responsibility, and innovation policy, all with an emphasis on pharmaceuticals. The book also intervenes in the debate over off-label drug marketing and the proper role of the FDA before and after a drug goes on the market. Dealing honestly and thoroughly with the FDA's successes and failures, these essays rethink the structure, function, and future of the agency and the effect policy innovations may have on regulatory institutions abroad.
Author: Institute of Medicine Publisher: National Academies Press ISBN: 030904491X Category : Medical Languages : en Pages : 225
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: John Braithwaite Publisher: Cambridge University Press ISBN: 9780521780339 Category : Business & Economics Languages : en Pages : 194
Book Description
How has the regulation of business shifted from national to global institutions? What are the mechanisms of globalization? Who are the key actors? What of democratic sovereignty? In which cases has globalization been successfully resisted? These questions are confronted across an amazing sweep of the critical areas of business regulation--from contract, intellectual property and corporations law, to trade, telecommunications, labor standards, drugs, food, transport and environment. This book examines the role played by global institutions such as the World Trade Organization, World Health Organization, the OECD, IMF, Moodys and the World Bank, as well as various NGOs and significant individuals. Incorporating both history and analysis, Global Business Regulation will become the standard reference for readers in business, law, politics, and international relations.
Author: Javed Ali Publisher: Academic Press ISBN: 0128222239 Category : Medical Languages : en Pages : 287
Book Description
Regulatory Affairs in the Pharmaceutical Industry is a comprehensive reference that compiles all the information available pertaining to regulatory procedures currently followed by the pharmaceutical industry. Designed to impart advanced knowledge and skills required to learn the various concepts of regulatory affairs, the content covers new drugs, generic drugs and their development, regulatory filings in different countries, different phases of clinical trials, and the submission of regulatory documents like IND (Investigational New Drug), NDA (New Drug Application) and ANDA (Abbreviated New Drug Application). Chapters cover documentation in the pharmaceutical industry, generic drug development, code of Federal Regulation (CFR), the ANDA regulatory approval process, the process and documentation for US registration of foreign drugs, the regulation of combination products and medical devices, the CTD and ECTD formats, and much more. Updated reference on drug approval processes in key global markets Provides comprehensive coverage of concepts and regulatory affairs Presents a concise compilation of the regulatory requirements of different countries Introduces the fundamentals of manufacturing controls and their regulatory importance
Author: Lorenzo Bairati Publisher: CEDAM ISBN: 8813382073 Category : Law Languages : en Pages : 207
Book Description
The evolution of fast-food governance is increasingly revealing of how global food systems law is going to develop. At the same time, fast-food rules decline differently depending on the legal system in which they are placed. This book compares the regulation of fast food in the European Union and the United States, analysing the interactions between internal and external, public and private, and global and local regulators. In particular, the regulatory aspects related to health (affected by the consumption of junk food) and the sustainability of fast-food products are analyzed from a comparative perspective. Lastly, a specific chapter is dedicated to the regulatory challenges related to the hamburger and its substitutes as a case study emblematic of the divergences and convergences between the EU and US legal systems.
Author: Michael T. Roberts Publisher: Edward Elgar Publishing ISBN: 1800374674 Category : Law Languages : en Pages : 581
Book Description
With contributions from over 30 international legal scholars, this topical Research Handbook on International Food Law provides a crucial and reflective examination of the rules, power dynamics, legal doctrines, societal norms, and frameworks that govern the modern global food system. The Research Handbook analyses the interlinkages between producers and consumers of food, as well as the environmental effects of the global food network and the repercussions on human health.
Author: Institute of Medicine Publisher: National Academies Press ISBN: 0309162904 Category : Medical Languages : en Pages : 141
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: National Academies of Sciences, Engineering, and Medicine
Author: National Academies of Sciences, Engineering, and Medicine
Author: Sam F Halabi
Author: Holly Fernandez Lynch
Author: Elisha Gray II Professor of Economics Emeritus Peter Temin
Author: Institute of Medicine
Author: John Braithwaite
Author: Javed Ali
Author: Lorenzo Bairati
Author: Michael T. Roberts
Author: Institute of Medicine