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Author: Margaret A. Hamburg Publisher: DIANE Publishing ISBN: 1437988377 Category : Medical Languages : en Pages : 37
Book Description
This report presents a new strategy by the Food and Drug Admin. (FDA) to meet the challenges posed by rapidly rising imports of FDA-regulated products and a complex global supply chain. The agency is planning to transform the way it conducts business and to act globally in order to promote and protect the health of U.S. consumers. Highlights of the report include four key elements needed to make the change: (1) The FDA will partner with its counterparts worldwide to create global coalitions of regulators focused on ensuring and improving global product safety and quality; (2) The coalitions of regulators will develop international data information systems and networks and increase the regular and proactive sharing of data and regulatory resources across world markets; (3) The FDA will build in additional information gathering and analysis capabilities with an increased focus on risk analytics and IT; (4) The FDA increasingly will leverage the efforts of public and private third parties and industry and allocate FDA resources based on risk. The report also discusses trends expected to be seen worldwide in upcoming years which have caused FDA to develop its new strategy. Figures. This is a print on demand report.
Author: Margaret A. Hamburg Publisher: DIANE Publishing ISBN: 1437988377 Category : Medical Languages : en Pages : 37
Book Description
This report presents a new strategy by the Food and Drug Admin. (FDA) to meet the challenges posed by rapidly rising imports of FDA-regulated products and a complex global supply chain. The agency is planning to transform the way it conducts business and to act globally in order to promote and protect the health of U.S. consumers. Highlights of the report include four key elements needed to make the change: (1) The FDA will partner with its counterparts worldwide to create global coalitions of regulators focused on ensuring and improving global product safety and quality; (2) The coalitions of regulators will develop international data information systems and networks and increase the regular and proactive sharing of data and regulatory resources across world markets; (3) The FDA will build in additional information gathering and analysis capabilities with an increased focus on risk analytics and IT; (4) The FDA increasingly will leverage the efforts of public and private third parties and industry and allocate FDA resources based on risk. The report also discusses trends expected to be seen worldwide in upcoming years which have caused FDA to develop its new strategy. Figures. This is a print on demand report.
Author: United States. Congress. House. Committee on Appropriations. Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Publisher: ISBN: Category : United States Languages : en Pages : 1096
Author: Institute of Medicine Publisher: National Academies Press ISBN: 030922408X Category : Medical Languages : en Pages : 366
Book Description
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.
Author: Preston W. Blevins Publisher: CRC Press ISBN: 1439849587 Category : Business & Economics Languages : en Pages : 342
Book Description
The global sourcing of ingredients has created complex supply chains, significant management challenges, and additional regulatory compliance requirements. This places tremendous pressure on food manufacturers, many of whom lack the knowledge, concepts, techniques, and procedures to comply with these increased requirements. Providing a roadmap for
Author: Roy Ahn Publisher: Springer ISBN: 1489975977 Category : Medical Languages : en Pages : 344
Book Description
This powerful resource identifies wide-scale health challenges facing a rapidly urbanizing planet--including key concerns in nutrition, health status, health care, and safety--and strategies toward possible solutions. Theoretical and empirical analysis focuses on maximizing the benefits of urban living and minimizing negative outcomes across areas for improvement (health education, maternal and child health) and threats to well-being (noise pollution, drug counterfeiting). For each challenge, contributors discuss implications for health, specific practices that fuel them, and emerging ideas for solving them efficiently and effectively. Not only are these issues of immediate salience, they will become dangerously urgent in years to come. Included in the coverage: Food fortification and other innovations to address child malnutrition. Anti-trafficking innovations, urbanization, and global health. Innovations to address global climate change in cities. Innovations in disaster preparedness: implications for urbanization and health. Medical diagnostic innovations in urban developing settings. The case for comprehensive, integrated, and standardized measures of health in cities. Recent studies suggest that urban areas will be a large majority in both the developing and developed worlds. Innovations to Address Urbanization & Global Health is a proactive idea book to be read by undergraduates, graduate students and researchers in public and urban health.
Author: United States. Congress. House. Committee on Appropriations. Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Publisher: ISBN: Category : United States Languages : en Pages : 1026
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: Institute of Medicine Publisher: National Academies Press ISBN: 0309284791 Category : Medical Languages : en Pages : 129
Book Description
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.
Author: Margaret A. Hamburg
Author: Margaret A. Hamburg
Author: 
Author: 
Author: United States. Congress. House. Committee on Appropriations. Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies
Author: Institute of Medicine
Author: Preston W. Blevins
Author: Roy Ahn
Author: United States. Congress. House. Committee on Appropriations. Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies
Author: Sam F Halabi
Author: Institute of Medicine