Food and Drug Regulation in an Era of Globalized Markets

Food and Drug Regulation in an Era of Globalized Markets
Author: Sam F Halabi
Publsiher: Academic Press
Total Pages: 264
Release: 2015-08-31
ISBN 10: 0128025506
ISBN 13: 9780128025505
Language: EN, FR, DE, ES & NL

Food and Drug Regulation in an Era of Globalized Markets Book Review:

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

FDA Warning Letters About Food Products

FDA Warning Letters About Food Products
Author: Joy Frestedt
Publsiher: Academic Press
Total Pages: 334
Release: 2017-08-29
ISBN 10: 0128093501
ISBN 13: 9780128093504
Language: EN, FR, DE, ES & NL

FDA Warning Letters About Food Products Book Review:

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

FDA in the Twenty First Century

FDA in the Twenty First Century
Author: Holly Fernandez Lynch,I. Glenn Cohen
Publsiher: Columbia University Press
Total Pages: 528
Release: 2015-09-08
ISBN 10: 0231540078
ISBN 13: 9780231540070
Language: EN, FR, DE, ES & NL

FDA in the Twenty First Century Book Review:

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.

Intellectual Property and the New International Economic Order

Intellectual Property and the New International Economic Order
Author: Sam F. Halabi
Publsiher: Cambridge University Press
Total Pages: 300
Release: 2018-04-30
ISBN 10: 1107177804
ISBN 13: 9781107177802
Language: EN, FR, DE, ES & NL

Intellectual Property and the New International Economic Order Book Review:

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

Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad

Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad
Author: Institute of Medicine,Board on Health Sciences Policy,Board on Global Health,Committee on Strengthening Core Elements of Food and Drug Regulatory Systems in Developing Countries
Publsiher: National Academies Press
Total Pages: 366
Release: 2012-09-03
ISBN 10: 030922408X
ISBN 13: 9780309224086
Language: EN, FR, DE, ES & NL

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

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.

Ensuring Global Food Safety

Ensuring Global Food Safety
Author: Aleksandra Martinovic,Sangsuk Oh,Huub Lelieveld
Publsiher: Academic Press
Total Pages: 528
Release: 2019-11
ISBN 10: 9780128160114
ISBN 13: 012816011X
Language: EN, FR, DE, ES & NL

Ensuring Global Food Safety Book Review:

Ensuring Global Food Safety: Exploring Global Harmonization, Second Edition, examines the policies and practices of food law which remain top contributors to food waste. This fully revised and updated edition offers a rational and multifaceted approach to the science-based issue of "what is safe for consumption?" and how creating a globally acceptable framework of microbiological, toxicological and nutritional standards can contribute to the alleviation of hunger and food insecurity in the world. Currently, many laws and regulations are so stringent that healthy food is destroyed based on scientifically incorrect information upon which laws and regulations are based. This book illuminates these issues, offering guidelines for moving toward a scientifically sound approach to food safety regulation that can also improve food security without putting consumers at risk. Presents the progress and current status of regulatory harmonization for food standards Provides a science-based foundation for global regulatory consensus Approaches challenges from a risk-benefit approach, also including safety assurance Includes global perspectives from governmental, academic and industry experts

Journal of the Association of Food and Drug Officials

Journal of the Association of Food and Drug Officials
Author: Anonim
Publsiher: Unknown
Total Pages: 329
Release: 2003
ISBN 10:
ISBN 13: CORNELL:31924097770832
Language: EN, FR, DE, ES & NL

Journal of the Association of Food and Drug Officials Book Review:

Viral Sovereignty and Technology Transfer

Viral Sovereignty and Technology Transfer
Author: Sam F. Halabi,Rebecca Katz
Publsiher: Cambridge University Press
Total Pages: 280
Release: 2020-05-31
ISBN 10: 1108484727
ISBN 13: 9781108484725
Language: EN, FR, DE, ES & NL

Viral Sovereignty and Technology Transfer Book Review:

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

Stronger Food and Drug Regulatory Systems Abroad

Stronger Food and Drug Regulatory Systems Abroad
Author: National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Global Health,Committee on Stronger Food and Drug Regulatory Systems Abroad
Publsiher: National Academies Press
Total Pages: 240
Release: 2020-04-09
ISBN 10: 0309670438
ISBN 13: 9780309670432
Language: EN, FR, DE, ES & NL

Stronger Food and Drug Regulatory Systems Abroad Book Review:

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.

Proceedings of the Annual Meeting

Proceedings of the     Annual Meeting
Author: American Society of International Law. Annual Meeting,American Society of International Law
Publsiher: Unknown
Total Pages: 329
Release: 2008
ISBN 10:
ISBN 13: PSU:000067334506
Language: EN, FR, DE, ES & NL

Proceedings of the Annual Meeting Book Review:

Food Wars

Food Wars
Author: Tim Lang,Michael Heasman
Publsiher: Earthscan
Total Pages: 365
Release: 2004
ISBN 10: 1853837016
ISBN 13: 9781853837012
Language: EN, FR, DE, ES & NL

Food Wars Book Review:

It is widely accepted in the scientific community that climate change is a reality, and that changes are happening with increasing rapidity. In this second edition, leading climate researcher Barrie Pittock revisits the effects that global warming is havi

The Corrosion of Medicine

The Corrosion of Medicine
Author: John P. Geyman
Publsiher: Unknown
Total Pages: 344
Release: 2008
ISBN 10:
ISBN 13: UOM:39015073962600
Language: EN, FR, DE, ES & NL

The Corrosion of Medicine Book Review:

Has the business "ethic" killed off the medical ethic, or is a cure still possible?

Global Business Regulation

Global Business Regulation
Author: John Braithwaite,Peter Drahos
Publsiher: Cambridge University Press
Total Pages: 722
Release: 2000-02-13
ISBN 10: 1107717507
ISBN 13: 9781107717503
Language: EN, FR, DE, ES & NL

Global Business Regulation Book Review:

Across an amazing sweep of the critical areas of business regulation - from contract, intellectual property and corporations law, to trade, telecommunications, labour standards, drugs, food, transport and environment - this book confronts the question of how the regulation of business has shifted from national to global institutions. Based on interviews with 500 international leaders in business and government, this book examines the role played by global institutions such as the WTO, the OECD, IMF, Moody's and the World Bank, as well as various NGOs and significant individuals. The authors argue that effective and decent global regulation depends on the determination of individuals to engage with powerful agendas and decision-making bodies that would otherwise be dominated by concentrated economic interests. This book will become a standard reference for readers in business, law, politics and international relations.

House of Commons Debates Official Report

House of Commons Debates  Official Report
Author: Canada. Parliament. House of Commons
Publsiher: Unknown
Total Pages: 329
Release: 2005
ISBN 10:
ISBN 13: OSU:32435076230028
Language: EN, FR, DE, ES & NL

House of Commons Debates Official Report Book Review:

Preparing for Future Products of Biotechnology

Preparing for Future Products of Biotechnology
Author: National Academies of Sciences, Engineering, and Medicine,Division on Earth and Life Studies,Board on Chemical Sciences and Technology,Board on Agriculture and Natural Resources,Board on Life Sciences,Committee on Future Biotechnology Products and Opportunities to Enhance Capabilities of the Biotechnology Regulatory System
Publsiher: National Academies Press
Total Pages: 230
Release: 2017-07-28
ISBN 10: 0309452058
ISBN 13: 9780309452052
Language: EN, FR, DE, ES & NL

Preparing for Future Products of Biotechnology Book Review:

Between 1973 and 2016, the ways to manipulate DNA to endow new characteristics in an organism (that is, biotechnology) have advanced, enabling the development of products that were not previously possible. What will the likely future products of biotechnology be over the next 5â€"10 years? What scientific capabilities, tools, and/or expertise may be needed by the regulatory agencies to ensure they make efficient and sound evaluations of the likely future products of biotechnology? Preparing for Future Products of Biotechnology analyzes the future landscape of biotechnology products and seeks to inform forthcoming policy making. This report identifies potential new risks and frameworks for risk assessment and areas in which the risks or lack of risks relating to the products of biotechnology are well understood.

Ensuring Global Food Safety

Ensuring Global Food Safety
Author: Christine Boisrobert,Aleksandra Stjepanovic,Sangsuk Oh,Huub Lelieveld
Publsiher: Academic Press
Total Pages: 472
Release: 2009-11-11
ISBN 10: 9780080889306
ISBN 13: 0080889301
Language: EN, FR, DE, ES & NL

Ensuring Global Food Safety Book Review:

Taking into account toxicity levels at normal consumption levels, intake per kg bodyweight and other acknowledged considerations, each chapter in this book will be based on one or more proven examples. It is intended to provide specific examples and potential improvements to the safety of the world's food supply, while also increasing the amount of food available to those in undernourished countries. This book is designed to to provide science-based tools for improving legislation and regulation. Benefits: Reduce amount of food destroyed due to difference in regulations between nations Positively impact the time-to-market of new food products by recognizing benefit of "one rule that applies to all" Use the comparison of regulations and resulting consequences to make appropriate, fully-informed decisions Employ proven science to obtain global consensus for regulations Understand how to harmonize test protocols and analytical methods for accurate measurement and evaluation Take advantage of using a risk/benefit based approach rather than risk/avoidance to maximize regulatory decisions

The Safe Food Imperative

The Safe Food Imperative
Author: Steven Jaffee,Spencer Henson,Laurian Unnevehr,Delia Grace,Emilie Cassou
Publsiher: World Bank Publications
Total Pages: 208
Release: 2018-12-11
ISBN 10: 1464813469
ISBN 13: 9781464813467
Language: EN, FR, DE, ES & NL

The Safe Food Imperative Book Review:

This report strengthens the economic case for increased public investment and more robust policy attention to food safety in low and middle income countries and provides guidance on ways to achieve significant, broad-based impact from such actions.

A Framework for Assessing Effects of the Food System

A Framework for Assessing Effects of the Food System
Author: National Research Council,Institute of Medicine,Board on Agriculture and Natural Resources,Food and Nutrition Board,Committee on a Framework for Assessing the Health, Environmental, and Social Effects of the Food System
Publsiher: National Academies Press
Total Pages: 444
Release: 2015-06-17
ISBN 10: 030930783X
ISBN 13: 9780309307833
Language: EN, FR, DE, ES & NL

A Framework for Assessing Effects of the Food System Book Review:

How we produce and consume food has a bigger impact on Americans' well-being than any other human activity. The food industry is the largest sector of our economy; food touches everything from our health to the environment, climate change, economic inequality, and the federal budget. From the earliest developments of agriculture, a major goal has been to attain sufficient foods that provide the energy and the nutrients needed for a healthy, active life. Over time, food production, processing, marketing, and consumption have evolved and become highly complex. The challenges of improving the food system in the 21st century will require systemic approaches that take full account of social, economic, ecological, and evolutionary factors. Policy or business interventions involving a segment of the food system often have consequences beyond the original issue the intervention was meant to address. A Framework for Assessing Effects of the Food System develops an analytical framework for assessing effects associated with the ways in which food is grown, processed, distributed, marketed, retailed, and consumed in the United States. The framework will allow users to recognize effects across the full food system, consider all domains and dimensions of effects, account for systems dynamics and complexities, and choose appropriate methods for analysis. This report provides example applications of the framework based on complex questions that are currently under debate: consumption of a healthy and safe diet, food security, animal welfare, and preserving the environment and its resources. A Framework for Assessing Effects of the Food System describes the U.S. food system and provides a brief history of its evolution into the current system. This report identifies some of the real and potential implications of the current system in terms of its health, environmental, and socioeconomic effects along with a sense for the complexities of the system, potential metrics, and some of the data needs that are required to assess the effects. The overview of the food system and the framework described in this report will be an essential resource for decision makers, researchers, and others to examine the possible impacts of alternative policies or agricultural or food processing practices.

Food and Drug Law Journal

Food and Drug Law Journal
Author: Anonim
Publsiher: Unknown
Total Pages: 329
Release: 1997
ISBN 10:
ISBN 13: STANFORD:36105061772757
Language: EN, FR, DE, ES & NL

Food and Drug Law Journal Book Review:

Global Standards

Global Standards
Author: U. S. Office of Technology Assessment Staff
Publsiher: Inspirations by Grace Lajoy
Total Pages: 119
Release: 1992
ISBN 10:
ISBN 13: IND:30000036368540
Language: EN, FR, DE, ES & NL

Global Standards Book Review: