Food And Drug Regulation In An Era Of Globalized Markets

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Food and Drug Regulation in an Era of Globalized Markets

Author : Sam F Halabi
Publisher : Academic Press
ISBN 13 : 0128025506
Total Pages : 258 pages
Book Rating : 4.1/5 (28 download)

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Book Synopsis Food and Drug Regulation in an Era of Globalized Markets by : Sam F Halabi

Download or read book Food and Drug Regulation in an Era of Globalized Markets written by Sam F Halabi and published by Academic Press. This book was released on 2015-08-31 with total page 258 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Regulating Medicines in a Globalized World

Author : National Academies of Sciences, Engineering, and Medicine
Publisher : National Academies Press
ISBN 13 : 0309498635
Total Pages : 169 pages
Book Rating : 4.3/5 (94 download)

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Book Synopsis Regulating Medicines in a Globalized World by : National Academies of Sciences, Engineering, and Medicine

Download or read book Regulating Medicines in a Globalized World written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2020-04-25 with total page 169 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

FDA in the Twenty-First Century

Author : Holly Fernandez Lynch
Publisher : Columbia University Press
ISBN 13 : 0231540078
Total Pages : 499 pages
Book Rating : 4.2/5 (315 download)

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Book Synopsis FDA in the Twenty-First Century by : Holly Fernandez Lynch

Download or read book FDA in the Twenty-First Century written by Holly Fernandez Lynch and published by Columbia University Press. This book was released on 2015-09-08 with total page 499 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Stronger Food and Drug Regulatory Systems Abroad

Author : National Academies of Sciences, Engineering, and Medicine
Publisher : National Academies Press
ISBN 13 : 0309670462
Total Pages : 243 pages
Book Rating : 4.3/5 (96 download)

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Book Synopsis Stronger Food and Drug Regulatory Systems Abroad by : National Academies of Sciences, Engineering, and Medicine

Download or read book Stronger Food and Drug Regulatory Systems Abroad written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2020-03-09 with total page 243 pages. Available in PDF, EPUB and Kindle. Book excerpt: Ensuring the safety of food and the quality and safety of medicines in a country is an important role of government, made more complicated by global manufacturing and international trade. By recent estimates, unsafe food kills over 400,000 people a year, a third of them children under 5, mostly in low- and middle-income countries; every year poor quality medicines cause about 70,000 excess deaths from childhood pneumonia and roughly 8,500 to 20,000 malaria deaths in sub-Saharan Africa alone. The Federal Drug Administration (FDA) Office of Global Policy and Strategy is charged with improving capacity of the agency's foreign counterpart offices and increasing understanding of the importance of regulatory systems for public health, development, and trade. At the request of the FDA, this study sets out a strategy to support good quality, wholesome food and safe, effective medical products around the world. Its goal is to build on the momentum for strengthening regulatory systems and to set a course for sustainability and continued progress. The 2012 report Ensuring Safe Food and Medical Products Through Stronger Regulatory Systems Abroad outlined strategies to secure international supply chains, emphasized capacity building and support for surveillance in low- and middle-income countries, and explored ways to facilitate work sharing among food and medical product regulatory agencies. This new study assess progress made and the current regulatory landscape.

Introduction to

Author : Holly Fernandez Lynch
Publisher :
ISBN 13 :
Total Pages : 0 pages
Book Rating : 4.:/5 (137 download)

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Book Synopsis Introduction to by : Holly Fernandez Lynch

Download or read book Introduction to written by Holly Fernandez Lynch and published by . This book was released on 2015 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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. This paper is the introduction to a book of 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. It discusses 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. It 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, contributors rethink the structure, function, and future of the agency and the effect policy innovations may have on regulatory institutions in other countries.

Intellectual Property and the New International Economic Order

Author : Sam F. Halabi
Publisher : Cambridge University Press
ISBN 13 : 1316835987
Total Pages : 256 pages
Book Rating : 4.3/5 (168 download)

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Book Synopsis Intellectual Property and the New International Economic Order by : Sam F. Halabi

Download or read book Intellectual Property and the New International Economic Order written by Sam F. Halabi and published by Cambridge University Press. This book was released on 2018-04-19 with total page 256 pages. Available in PDF, EPUB and Kindle. Book excerpt: In economic sectors crucial to human welfare – agriculture, education, and medicine – a small number of firms control global markets, primarily by enforcing intellectual property (IP) rights incorporated into trade agreements made in the 1980s onward. Such rights include patents on seeds and medicines, copyrights for educational texts, and trademarks in consumer products. According to conventional wisdom, these agreements likewise ended hopes for a 'New International Economic Order,' under which wealth would be redistributed from rich countries to poor. Sam F. Halabi turns this conventional wisdom on its head by demonstrating that the New International Economic Order never faded, but rather was redirected by other treaties, formed outside the nominally economic sphere, that protected poor countries' interests in education, health, and nutrition and resulted in redistribution and regulation. This illuminating work should be read by anyone seeking a nuanced view of how IP is shaping the global knowledge economy.

Taking Your Medicine

Author : Elisha Gray II Professor of Economics Emeritus Peter Temin
Publisher :
ISBN 13 : 9780674592759
Total Pages : 288 pages
Book Rating : 4.5/5 (927 download)

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Book Synopsis Taking Your Medicine by : Elisha Gray II Professor of Economics Emeritus Peter Temin

Download or read book Taking Your Medicine written by Elisha Gray II Professor of Economics Emeritus Peter Temin and published by . This book was released on 2013-10-01 with total page 288 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Agrifood market regulation and contractual relationships in the light of directive (eu) 633/2019

Author : Raffaele Torino
Publisher : Roma TrE-Press
ISBN 13 :
Total Pages : 449 pages
Book Rating : 4.2/5 (597 download)

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Book Synopsis Agrifood market regulation and contractual relationships in the light of directive (eu) 633/2019 by : Raffaele Torino

Download or read book Agrifood market regulation and contractual relationships in the light of directive (eu) 633/2019 written by Raffaele Torino and published by Roma TrE-Press. This book was released on 2023-10-05 with total page 449 pages. Available in PDF, EPUB and Kindle. Book excerpt: Il volume collettaneo analizza le tematiche connesse alla disciplina dei rapporti tra i diversi attori della filiera agroalimentare alla luce della Direttiva UE 2019/633 “in materia di pratiche commerciali sleali nei rapporti tra imprese nella filiera agricola e alimentare” e della sua attuazione negli Stati membri, nell’ottica della più ampia problematica della disciplina del mercato agroalimentare. In tale prospettiva, nella prima parte del volume la disciplina dei rapporti contrattuali della filiera agroalimentare viene inquadrata nell’ambito della PAC e della disciplina della concorrenza, evidenziandosi altresì le connessioni con altri profili di rilievo; nella seconda parte, l’analisi si concentra sull’attuazione della Direttiva UE 2019/633 nei diversi Stati membri, al fine di evidenziare i punti di forza e le debolezze del mutato quadro normativo europeo. DOI: 10.13134/979-12-5977-231-2

Global Business Regulation

Author : John Braithwaite
Publisher : Cambridge University Press
ISBN 13 : 9780521780339
Total Pages : 194 pages
Book Rating : 4.7/5 (83 download)

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Book Synopsis Global Business Regulation by : John Braithwaite

Download or read book Global Business Regulation written by John Braithwaite and published by Cambridge University Press. This book was released on 2000-02-13 with total page 194 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Fast-Food Law: a Comparative Perspective

Author : Lorenzo Bairati
Publisher : CEDAM
ISBN 13 : 8813382073
Total Pages : 207 pages
Book Rating : 4.8/5 (133 download)

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Book Synopsis Fast-Food Law: a Comparative Perspective by : Lorenzo Bairati

Download or read book Fast-Food Law: a Comparative Perspective written by Lorenzo Bairati and published by CEDAM. This book was released on 2022-08-29 with total page 207 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Research Handbook on International Food Law

Author : Michael T. Roberts
Publisher : Edward Elgar Publishing
ISBN 13 : 1800374674
Total Pages : 581 pages
Book Rating : 4.8/5 (3 download)

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Book Synopsis Research Handbook on International Food Law by : Michael T. Roberts

Download or read book Research Handbook on International Food Law written by Michael T. Roberts and published by Edward Elgar Publishing. This book was released on 2023-11-03 with total page 581 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

FDA Warning Letters About Food Products

Author : Joy Frestedt
Publisher : Academic Press
ISBN 13 : 0128093501
Total Pages : 336 pages
Book Rating : 4.1/5 (28 download)

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Book Synopsis FDA Warning Letters About Food Products by : Joy Frestedt

Download or read book FDA Warning Letters About Food Products written by Joy Frestedt and published by Academic Press. This book was released on 2017-08-29 with total page 336 pages. Available in PDF, EPUB and Kindle. Book excerpt: FDA Warning Letters About Food Products: How to Avoid or Respond to Citations uses examples of FDA warning letters about food products as training tools to discuss important quality and manufacturing issues encountered by food companies around the world as they bring food products into the US market. Focused specifically on FDA warning letters surrounding new dietary ingredients and dietary supplements, the book first introduces FDA warning letters in general. Each chapter then focuses on specific issues identified, including HAACP/quality systems, imports/exports, food contact issues, etc. This book helps the food industry train professional team members (across the spectrum of experience levels) to avoid common issues often cited in warning letters. It serves both as an authoritative reference on the common types of warning letters issued to food companies today, and as a guide to best practices for food manufacturers. Includes a range of specific warning letters as case studies and examples of method application Synthesizes often complex information into a clear presentation of FDA warning letters and how to deal with them Describes techniques and methodologies to guide readers to the solution most appropriate for their scenario

Food Safety and Technology Governance

Author : Kuei-Jung Ni
Publisher : Taylor & Francis
ISBN 13 : 100062725X
Total Pages : 210 pages
Book Rating : 4.0/5 (6 download)

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Book Synopsis Food Safety and Technology Governance by : Kuei-Jung Ni

Download or read book Food Safety and Technology Governance written by Kuei-Jung Ni and published by Taylor & Francis. This book was released on 2022-08-31 with total page 210 pages. Available in PDF, EPUB and Kindle. Book excerpt: Recent advances in agri-food technology have brought increasing complexity and emerging challenges to food safety regulation and governance, with many countries greatly divided in their regulatory approaches. As more advanced CRISPR-based gene-editing technologies and novel foods such as cloned animal products, non-traditional plants, nanofood, and plant-based meat are rapidly being developed, debates arise as to whether the existing models of governance require revision to ensure consumer safety. Of equal importance is the extensive use of pesticides, additives, and animal drugs, which raise concerns over the methods and approaches of government approval and phasing out of potentially risk-causing chemicals. Heightened public criticism of food safety and technology poses a signifi cant challenge to governments around the world, which struggle to strike a proper balance between technocracy- and democracy-oriented risk governance models. Drawing on expertise from the United States, European Union, Japan, China, Korea, Association of South East Asian Nations, Malaysia, and Taiwan, this book explores existing and emerging issues of food law and policy in the context of technology governance to offer an overarching framework for the interaction between food regulation and technology. It will be essential reading for academics, students, and practitioners with an interest in food law and policy, agricultural law and policy, and food safety and nutrition studies.

An Overview of FDA Regulated Products

Author : Eunjoo Pacifici
Publisher : Academic Press
ISBN 13 : 0128111569
Total Pages : 292 pages
Book Rating : 4.1/5 (281 download)

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Book Synopsis An Overview of FDA Regulated Products by : Eunjoo Pacifici

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 292 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

Research Handbook on Transnational Environmental Law

Author : Veerle Heyvaert
Publisher : Edward Elgar Publishing
ISBN 13 : 1788119630
Total Pages : 416 pages
Book Rating : 4.7/5 (881 download)

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Book Synopsis Research Handbook on Transnational Environmental Law by : Veerle Heyvaert

Download or read book Research Handbook on Transnational Environmental Law written by Veerle Heyvaert and published by Edward Elgar Publishing. This book was released on 2020-11-27 with total page 416 pages. Available in PDF, EPUB and Kindle. Book excerpt: This illuminating Research Handbook offers a detailed overview and critical discussion of the key themes and perspectives that characterize the burgeoning research area of transnational environmental law. Varied perspectives from leading and emerging scholars are brought together to deliver methodological and conceptual frameworks for future research, whilst providing an original view on this emerging field of law.

Outbreak

Author : Timothy D. Lytton
Publisher : University of Chicago Press
ISBN 13 : 022661168X
Total Pages : 357 pages
Book Rating : 4.2/5 (266 download)

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Book Synopsis Outbreak by : Timothy D. Lytton

Download or read book Outbreak written by Timothy D. Lytton and published by University of Chicago Press. This book was released on 2019-04-16 with total page 357 pages. Available in PDF, EPUB and Kindle. Book excerpt: Foodborne illness is a big problem. Wash those chicken breasts, and you’re likely to spread Salmonella to your countertops, kitchen towels, and other foods nearby. Even salad greens can become biohazards when toxic strains of E. coli inhabit the water used to irrigate crops. All told, contaminated food causes 48 million illnesses, 128,000 hospitalizations, and 3,000 deaths each year in the United States. With Outbreak, Timothy D. Lytton provides an up-to-date history and analysis of the US food safety system. He pays particular attention to important but frequently overlooked elements of the system, including private audits and liability insurance. Lytton chronicles efforts dating back to the 1800s to combat widespread contamination by pathogens such as E. coli and salmonella that have become frighteningly familiar to consumers. Over time, deadly foodborne illness outbreaks caused by infected milk, poison hamburgers, and tainted spinach have spurred steady scientific and technological advances in food safety. Nevertheless, problems persist. Inadequate agency budgets restrict the reach of government regulation. Pressure from consumers to keep prices down constrains industry investments in safety. The limits of scientific knowledge leave experts unable to assess policies’ effectiveness and whether measures designed to reduce contamination have actually improved public health. Outbreak offers practical reforms that will strengthen the food safety system’s capacity to learn from its mistakes and identify cost-effective food safety efforts capable of producing measurable public health benefits.

Enhancing Food Safety

Author : National Research Council
Publisher : National Academies Press
ISBN 13 : 0309163587
Total Pages : 589 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Enhancing Food Safety by : National Research Council

Download or read book Enhancing Food Safety written by National Research Council and published by National Academies Press. This book was released on 2010-11-04 with total page 589 pages. Available in PDF, EPUB and Kindle. Book excerpt: Recent outbreaks of illnesses traced to contaminated sprouts and lettuce illustrate the holes that exist in the system for monitoring problems and preventing foodborne diseases. Although it is not solely responsible for ensuring the safety of the nation's food supply, the U.S. Food and Drug Administration (FDA) oversees monitoring and intervention for 80 percent of the food supply. The U.S. Food and Drug Administration's abilities to discover potential threats to food safety and prevent outbreaks of foodborne illness are hampered by impediments to efficient use of its limited resources and a piecemeal approach to gathering and using information on risks. Enhancing Food Safety: The Role of the Food and Drug Administration, a new book from the Institute of Medicine and the National Research Council, responds to a congressional request for recommendations on how to close gaps in FDA's food safety systems. Enhancing Food Safety begins with a brief review of the Food Protection Plan (FPP), FDA's food safety philosophy developed in 2007. The lack of sufficient detail and specific strategies in the FPP renders it ineffectual. The book stresses the need for FPP to evolve and be supported by the type of strategic planning described in these pages. It also explores the development and implementation of a stronger, more effective food safety system built on a risk-based approach to food safety management. Conclusions and recommendations include adopting a risk-based decision-making approach to food safety; creating a data surveillance and research infrastructure; integrating federal, state, and local government food safety programs; enhancing efficiency of inspections; and more. Although food safety is the responsibility of everyone, from producers to consumers, the FDA and other regulatory agencies have an essential role. In many instances, the FDA must carry out this responsibility against a backdrop of multiple stakeholder interests, inadequate resources, and competing priorities. Of interest to the food production industry, consumer advocacy groups, health care professionals, and others, Enhancing Food Safety provides the FDA and Congress with a course of action that will enable the agency to become more efficient and effective in carrying out its food safety mission in a rapidly changing world.