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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: 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: 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: 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: National Academies of Sciences, Engineering, and Medicine Publisher: National Academies Press ISBN: 0309670462 Category : Medical Languages : en Pages : 243
Book Description
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.
Author: Holly Fernandez Lynch Publisher: ISBN: Category : Languages : en Pages : 0
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. 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.
Author: Sam F. Halabi Publisher: Cambridge University Press ISBN: 1316835987 Category : Law Languages : en Pages : 256
Book Description
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.
Author: Raffaele Torino Publisher: Roma TrE-Press ISBN: Category : Law Languages : en Pages : 449
Book Description
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
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: 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: Sam F Halabi
Author: Sam F Halabi
Author: National Academies of Sciences, Engineering, and Medicine
Author: Holly Fernandez Lynch
Author: National Academies of Sciences, Engineering, and Medicine
Author: Holly Fernandez Lynch
Author: Sam F. Halabi
Author: Elisha Gray II Professor of Economics Emeritus Peter Temin
Author: Raffaele Torino
Author: John Braithwaite
Author: Lorenzo Bairati