Food And Drug Regulation In An Era Of Globalized Markets

Autor: Sam F Halabi
Publisher: Academic Press
ISBN: 0128025506
File Size: 58,13 MB
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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 In The Twenty First Century

Autor: I. Glenn Cohen
Publisher: Columbia University Press
ISBN: 0231540078
File Size: 61,25 MB
Format: PDF, Mobi
Read: 2019
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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, contributors rethink the structure, function, and future of the agency and the effect policy innovations may have on regulatory institutions in other countries.

Import Safety

Autor: Cary Coglianese
Publisher: University of Pennsylvania Press
ISBN: 9780812242225
File Size: 78,28 MB
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Written by leading scholars and analysts, the essays in Import Safety provide background and policy guidance on improving consumer safety in imported food, pharmaceuticals, medical devices, and toys and other consumer products aimed at children.

Global Clinical Trials

Autor: Richard Chin
Publisher: Academic Press
ISBN: 9780123815385
File Size: 43,64 MB
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This book will explore the great opportunities and challenges which exist in conducting clinical trials in developing countries. By exploring the various regulations specific to the major players and providing insight into the logistical challenges including language barriers, this book provides a working tool for clinical researchers and administrators to navigate the intricacies of clinical trials in developing countries. Important topics such as ethical issues will be handled very carefully to highlight the significant differences of conducting this work in various jurisdictions. Overall, it will present a clear and comprehensive guide to the ins-and-outs of clinical trials in various countries to assist in design, development, and effectiveness of these trials. Contributors include high-profile, respected figures who have paved the way for clinical trials in developing countries Provides hands-on tools for regulatory and legal requirements and qualification, design, management, and reporting Case studies outline successes, failures, lessons learned and prospects for future collaboration Includes country-specific guidelines for the most utilized countries Foreword by David Feigel, former Head of CDRH at FDA

Countering The Problem Of Falsified And Substandard Drugs

Autor: Committee on Understanding the Global Public Health Implications of Substandard, Falsified, and Counterfeit Medical Products
Publisher: National Academies Press
ISBN: 0309269393
File Size: 11,28 MB
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The adulteration and fraudulent manufacture of medicines is an old problem, vastly aggravated by modern manufacturing and trade. In the last decade, impotent antimicrobial drugs have compromised the treatment of many deadly diseases in poor countries. More recently, negligent production at a Massachusetts compounding pharmacy sickened hundreds of Americans. While the national drugs regulatory authority (hereafter, the regulatory authority) is responsible for the safety of a country's drug supply, no single country can entirely guarantee this today. The once common use of the term counterfeit to describe any drug that is not what it claims to be is at the heart of the argument. In a narrow, legal sense a counterfeit drug is one that infringes on a registered trademark. The lay meaning is much broader, including any drug made with intentional deceit. Some generic drug companies and civil society groups object to calling bad medicines counterfeit, seeing it as the deliberate conflation of public health and intellectual property concerns. Countering the Problem of Falsified and Substandard Drugs accepts the narrow meaning of counterfeit, and, because the nuances of trademark infringement must be dealt with by courts, case by case, the report does not discuss the problem of counterfeit medicines.

Food Wars

Autor: Tim Lang
Publisher: Earthscan
ISBN: 1853837016
File Size: 33,47 MB
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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

Global Business Regulation

Autor: John Braithwaite
Publisher: Cambridge University Press
ISBN: 1107717507
File Size: 43,17 MB
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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.

The Truth About The Drug Companies

Autor: Marcia Angell
Publisher: Random House Incorporated
ISBN: 0375760946
File Size: 24,74 MB
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A physician and former editor-in-chief of The New England Journal of Medicine provides an explosive critique of the pharmaceutical industry, detailing its dangerous influence on medical research, education, and physicians; exposing the reasons behind the spiraling prescription drug prices; and proposing a program of vital reforms. Reprint.

Global Management Of Infectious Disease After Ebola

Autor: Sam F. Halabi
Publisher: Oxford University Press
ISBN: 0190604883
File Size: 35,23 MB
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The 2014-2015 Ebola outbreak in West Africa shocked the world with its devastation and its rapid migration to multiple continents. As the systems meant to respond to this sort of epidemic failed, the disease exposed not just weaknesses in international infectious disease surveillance and management, but the failures of governments, humanitarian organizations, and international institutions to handle the legal, ethical, and economic questions that arose with an event of this scale. GLOBAL MANAGEMENT OF INFECTIOUS DISEASE AFTER EBOLA unites the insights of Ebola's first responders with those the world's foremost experts in law, economics, vaccine development, and global migration to identify missed opportunities from the Ebola crisis -- and to apply these lessons to emerging infectious disease threats. Framed with critical discussions of both the global health financing infrastructures that precipitated the response and the ethical and human rights dilemmas that resulted from it, this volume is much more than postmortem to an outbreak: it is a vital, sometimes damning examination of where we've been and where we're going in the face of emerging infectious diseases.