Food and Drug Regulation in an Era of Globalized Markets Book

Food and Drug Regulation in an Era of Globalized Markets


  • Author : Sam Halabi
  • Publisher : Academic Press
  • Release Date : 2015-08-01
  • Genre: Uncategoriezed
  • Pages : 264
  • ISBN 10 : 0128023112

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Food and Drug Regulation in an Era of Globalized Markets 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

Food and Drug Regulation in an Era of Globalized Markets Book

Food and Drug Regulation in an Era of Globalized Markets


  • Author : Sam F Halabi
  • Publisher : Academic Press
  • Release Date : 2015-08-31
  • Genre: Technology & Engineering
  • Pages : 264
  • ISBN 10 : 9780128025505

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Food and Drug Regulation in an Era of Globalized Markets 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 Book

Regulating Medicines in a Globalized World


  • Author : National Academies of Sciences, Engineering, and Medicine
  • Publisher : National Academies Press
  • Release Date : 2020-03-25
  • Genre: Medical
  • Pages : 168
  • ISBN 10 : 9780309498661

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Regulating Medicines in a Globalized World 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.

International Regulatory Harmonization Amid Globalization of Drug Development Book

International Regulatory Harmonization Amid Globalization of Drug Development


  • Author : Institute of Medicine
  • Publisher : National Academies Press
  • Release Date : 2013-11-24
  • Genre: Medical
  • Pages : 129
  • ISBN 10 : 9780309284790

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International Regulatory Harmonization Amid Globalization of Drug Development Excerpt :

The past several decades have been a time of rapid globalization in the development, manufacture, marketing, and distribution of medical products and technologies. Increasingly, research on the safety and effectiveness of new drugs is being conducted in countries with little experience in regulation of medical product development. Demand has been increasing for globally harmonized, science-based standards for the development and evaluation of the safety, quality, and efficacy of medical products. Consistency of such standards could improve the efficiency and clarity of the drug development and evaluation process and, ultimately, promote and enhance product quality and the public health. To explore the need and prospects for greater international regulatory harmonization for drug development, the IOM Forum on Drug Discovery, Development, and Translation hosted a workshop on February 13-14, 2013. Discussions at the workshop helped identify principles, potential approaches, and strategies to advance the development or evolution of more harmonized regulatory standards. This document summarizes the workshop.

Intellectual Property and the New International Economic Order Book

Intellectual Property and the New International Economic Order


  • Author : Sam F. Halabi
  • Publisher : Cambridge University Press
  • Release Date : 2018-04-19
  • Genre: Business & Economics
  • Pages : 255
  • ISBN 10 : 9781107177802

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Intellectual Property and the New International Economic Order Excerpt :

Developing countries have quietly constructed a network of international agreements that redistribute wealth from the rich to the poor.

Viral Sovereignty and Technology Transfer Book

Viral Sovereignty and Technology Transfer


  • Author : Sam F. Halabi
  • Publisher : Cambridge University Press
  • Release Date : 2020-06-11
  • Genre: Law
  • Pages : 237
  • ISBN 10 : 9781108484725

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Viral Sovereignty and Technology Transfer Excerpt :

Sharing biological resources-critical for new medicines and vaccines-has declined as countries and scientists dispute rights over research.

Fast Food Law  a Comparative Perspective Book

Fast Food Law a Comparative Perspective


  • Author : Lorenzo Bairati
  • Publisher : CEDAM
  • Release Date : 2022-08-29
  • Genre: Law
  • Pages : 207
  • ISBN 10 : 9788813382070

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Fast Food Law a Comparative Perspective 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.

Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad Book

Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad


  • Author : Institute of Medicine
  • Publisher : National Academies Press
  • Release Date : 2012-09-03
  • Genre: Medical
  • Pages : 366
  • ISBN 10 : 9780309224086

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Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad Excerpt :

A very high portion of the seafood we eat comes from abroad, mainly from China and Southeast Asia, and most of the active ingredients in medicines we take originate in other countries. Many low- and middle-income countries have lower labor costs and fewer and less stringent environmental regulations than the United States, making them attractive places to produce food and chemical ingredients for export. Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad explains that the diversity and scale of imports makes it impractical for U.S. Food and Drug Administration (FDA) border inspections to be sufficient to ensure product purity and safety, and incidents such as American deaths due to adulterated heparin imported from China propelled the problem into public awareness. The Institute of Medicine Committee on Strengthening Core Elements of Regulatory Systems in Developing Countries took up the vital task of helping the FDA to cope with the reality that so much of the food, drugs, biologics, and medical products consumed in the United States originate in countries with less-robust regulatory systems. Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad describes the ways the United States can help strengthen regulatory systems in low and middle income countries and promote cross-border partnerships - including government, industry, and academia - to foster regulatory science and build a core of regulatory professionals. This report also emphasizes an array of practical approaches to ensure sound regulatory practices in today's interconnected world.

Food Safety and Technology Governance Book

Food Safety and Technology Governance


  • Author : Ching-Fu Lin
  • Publisher : Taylor & Francis
  • Release Date : 2022-08-05
  • Genre: Law
  • Pages : 256
  • ISBN 10 : 9781000627251

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Food Safety and Technology Governance Excerpt :

Recent advances in agri-food technology have brought about 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 significant 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.

Research Handbook on Transnational Environmental Law Book

Research Handbook on Transnational Environmental Law


  • Author : Veerle Heyvaert
  • Publisher : Edward Elgar Publishing
  • Release Date : 2020-11-27
  • Genre: Law
  • Pages : 416
  • ISBN 10 : 9781788119634

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Research Handbook on Transnational Environmental Law 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.

FDA in the Twenty First Century Book

FDA in the Twenty First Century


  • Author : Holly Fernandez Lynch
  • Publisher : Columbia University Press
  • Release Date : 2015-09-08
  • Genre: Business & Economics
  • Pages : 528
  • ISBN 10 : 9780231540070

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FDA in the Twenty First Century 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.

FDA Warning Letters About Food Products Book

FDA Warning Letters About Food Products


  • Author : Joy Frestedt
  • Publisher : Academic Press
  • Release Date : 2017-08-29
  • Genre: Law
  • Pages : 334
  • ISBN 10 : 9780128093504

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FDA Warning Letters About Food Products 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

An Overview of FDA Regulated Products Book

An Overview of FDA Regulated Products


  • Author : Eunjoo Pacifici
  • Publisher : Academic Press
  • Release Date : 2018-06-13
  • Genre: Medical
  • Pages : 280
  • ISBN 10 : 9780128111567

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An Overview of FDA Regulated Products 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

Outbreak Book

Outbreak


  • Author : Timothy D. Lytton
  • Publisher : University of Chicago Press
  • Release Date : 2019-04-16
  • Genre: Law
  • Pages : 384
  • ISBN 10 : 9780226611716

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Outbreak 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.

Law and Policy for a New Economy Book

Law and Policy for a New Economy


  • Author : Melissa K. Scanlan
  • Publisher : Edward Elgar Publishing
  • Release Date : 2017-05-26
  • Genre: Uncategoriezed
  • Pages : 320
  • ISBN 10 : 9781786434524

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Law and Policy for a New Economy Excerpt :

This book makes the case for a New Environmentalism, and using a systems change approach, takes the reader through ideas for reorienting the economy. It addresses the laws and policies needed to support the emergence of a new economy across a variety of major areas – from energy to food, across common pool resources, and shifting investments to capitalize locally-connected and mission-driven businesses. The authors take the approach that the challenges are much broader than setting parameters around pollution, and go to the heart of the dominant global political economy. It explores the values needed to transform our current economic system into a new economy supportive of ecological integrity, social justice, and vibrant democracy.