Pathway To Global Product Safety And Quality

Author : Margaret A. Hamburg
Publisher : DIANE Publishing
Page : 37 pages
File Size : 54,8 Mb
Release : 2012-10-07
Category : Medical
ISBN : 9781437988376

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Pathway to Global Product Safety and Quality by Margaret A. Hamburg Pdf

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 : National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Global Health,Committee on Stronger Food and Drug Regulatory Systems Abroad
Publisher : National Academies Press
Page : 243 pages
File Size : 50,9 Mb
Release : 2020-03-09
Category : Medical
ISBN : 9780309670463

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Stronger Food and Drug Regulatory Systems Abroad by National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Global Health,Committee on Stronger Food and Drug Regulatory Systems Abroad Pdf

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 : Rick Ng
Publisher : John Wiley & Sons
Page : 554 pages
File Size : 41,5 Mb
Release : 2015-06-22
Category : Science
ISBN : 9781118907276

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Drugs by Rick Ng Pdf

The third edition of this best-selling book continues to offer a user-friendly, step-by-step introduction to all the key processes involved in bringing a drug to the market, including the performance of pre-clinical studies, the conduct of human clinical trials, regulatory controls, and even the manufacturing processes for pharmaceutical products. Concise and easy to read, Drugs: From Discovery to Approval, Third Edition quickly introduces basic concepts, then moves on to discuss target selection and the drug discovery process for both small and large molecular drugs. The third edition incorporates the latest developments and updates in the pharmaceutical community, provides more comprehensive coverage of topics, and includes more materials and case studies suited to college and university use. Biotechnology is a dynamic field with changes across R&D, clinical trials, manufacturing and regulatory processes, and the third edition of the text provides timely updates for those in this rapidly growing field.

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
Publisher : National Academies Press
Page : 366 pages
File Size : 42,5 Mb
Release : 2012-09-03
Category : Medical
ISBN : 9780309224086

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Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad by 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 Pdf

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 : United States. Congress. House. Committee on Appropriations. Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies
Publisher : Unknown
Page : 1096 pages
File Size : 40,9 Mb
Release : 2014
Category : United States
ISBN : IND:30000144735911

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Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations for 2015 by United States. Congress. House. Committee on Appropriations. Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Pdf

Author : Joel I. Shalowitz
Publisher : John Wiley & Sons
Page : 720 pages
File Size : 51,8 Mb
Release : 2019-07-03
Category : Medical
ISBN : 9781118418345

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The U.S. Healthcare System by Joel I. Shalowitz Pdf

Provides a diverse, multi-faceted approach to health care evaluation and management The U.S. Health Care System: Origins, Organization and Opportunities provides a comprehensive introduction and resource for understanding healthcare management in the United States. It brings together the many “moving parts” of this large and varied system to provide both a bird’s-eye view as well as relevant details of the complex mechanisms at work. By focusing on stakeholders and their interests, this book analyzes the value propositions of the buyers and sellers of healthcare products and services along with the interests of patients. The book begins with a presentation of frameworks for understanding the structure of the healthcare system and its dynamic stakeholder inter-relationships. The chapters that follow each begin with their social and historical origins, so the reader can fully appreciate how that area evolved. The next sections on each topic describe the current environment and opportunities for improvement. Throughout, the learning objectives focus on three areas: frameworks for understanding issues, essential factual knowledge, and resources to keep the reader keep up to date. Healthcare is a rapidly evolving field, due to the regulatory and business environments as well as the advance of science. To keep the content current, online updates are provided at: www.HealthcareInsights.MD. This website also offers a weekday blog of important/interesting news and teaching notes/class discussion suggestions for instructors who use the book as a text. The U.S. Health Care System: Origins, Organization and Opportunities is an ideal textbook for healthcare courses in MBA, MPH, MHA, and public policy/administration programs. In piloting the content, over the past several years the author has successfully used drafts of chapters in his Healthcare Systems course for MBA and MPH students at Northwestern University. The book is also useful for novice or seasoned suppliers, payers and providers who work across the healthcare field and want a wider or deeper understanding of the entire system.

Author : United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health
Publisher : Unknown
Page : 212 pages
File Size : 48,6 Mb
Release : 2013
Category : Biological products
ISBN : MINN:31951D03670965R

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Review of the Proposed Generic Drug and Biosimilars User Fees and Further Examination of Drug Shortages by United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health Pdf

Author : I. Glenn Cohen,Nita A. Farahany,Henry T. Greely,Carmel Shachar
Publisher : Cambridge University Press
Page : 303 pages
File Size : 46,6 Mb
Release : 2021-09-16
Category : Law
ISBN : 9781108836616

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Consumer Genetic Technologies by I. Glenn Cohen,Nita A. Farahany,Henry T. Greely,Carmel Shachar Pdf

Examines the ethical, legal, and regulatory challenges presented as genomics become commonplace, easily available consumer products.

Author : Sam F Halabi
Publisher : Academic Press
Page : 264 pages
File Size : 52,7 Mb
Release : 2015-08-31
Category : Technology & Engineering
ISBN : 9780128025505

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Food and Drug Regulation in an Era of Globalized Markets by Sam F Halabi Pdf

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 : United States. Congress. Senate. Committee on Health, Education, Labor, and Pensions
Publisher : Unknown
Page : 96 pages
File Size : 40,9 Mb
Release : 2014
Category : Drug adulteration
ISBN : MINN:31951D036475171

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Securing the Pharmaceutical Supply Chain by United States. Congress. Senate. Committee on Health, Education, Labor, and Pensions Pdf

Author : Mary Zeiss Stange,Carol K. Oyster,Jane E. Sloan
Publisher : SAGE Publications
Page : 1258 pages
File Size : 42,7 Mb
Release : 2013-01-09
Category : Social Science
ISBN : 9781452270685

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The Multimedia Encyclopedia of Women in Today's World by Mary Zeiss Stange,Carol K. Oyster,Jane E. Sloan Pdf

This e-only volume expands and updates the original 4-volume Encyclopedia of Women in Today's World (2011), offering a wide range of new entries and new multimedia content. The entries reflect such developments as the Arab Spring that brought women's issues in the Islamic world into sharp relief, the domination of female athletes among medal winners at the London 2012 Olympics, nine more women joining the ranks of democratically elected heads of state, and much more. The 475 articles in this e-only update (accompanied by photos and video clips) supplement the themes established in the original edition, providing a vibrant collection of entries dealing with contemporary women's issues around the world.

Author : Barbara B. Flynn,Xiande Zhao
Publisher : CRC Press
Page : 416 pages
File Size : 54,9 Mb
Release : 2014-11-21
Category : Business & Economics
ISBN : 9781439815564

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Global Supply Chain Quality Management by Barbara B. Flynn,Xiande Zhao Pdf

This book draws together key insights from the relevant literature across diverse disciplines and presents detailed research case studies of six extended global supply chains in three industries: toys, food, and pharmaceuticals. These case studies cover U.S. companies with supply chains that extend into China and include the perspectives of U.S. and Chinese executives. The book then presents a conceptual model that synthesizes the literature and case studies, and describes the ways in which alternative product recall strategies influence consumers' perception of an organization's corporate social legitimacy and consumers' future purchasing behaviors.

Author : United States. Congress. House. Committee on Appropriations. Subcommittee on the Departments of Labor, Health and Human Services, Education, and Related Agencies
Publisher : Unknown
Page : 804 pages
File Size : 51,5 Mb
Release : 2013
Category : Administrative agencies
ISBN : STANFORD:36105050652689

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Departments of Labor, Health and Human Services, Education, and Related Agencies Appropriations for 2014: Top management challenges at the Departments of Labor, Health and Human Services, and Education: perspective from the Inspector General; regulatory approaches to foster economic growth; Secretary of Education; budget hearing: Department of Labor by United States. Congress. House. Committee on Appropriations. Subcommittee on the Departments of Labor, Health and Human Services, Education, and Related Agencies Pdf

Author : United States. Congress. House. Committee on Appropriations. Subcommittee on the Departments of Labor, Health and Human Services, Education, and Related Agencies
Publisher : Unknown
Page : 804 pages
File Size : 51,7 Mb
Release : 2013
Category : Administrative agencies
ISBN : UCR:31210023707704

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Departments of Labor, Health and Human Services, Education, and Related Agencies Appropriations for 2014: Department of Education FY 2014 budget justifications by United States. Congress. House. Committee on Appropriations. Subcommittee on the Departments of Labor, Health and Human Services, Education, and Related Agencies Pdf

Author : Roy Ahn,Thomas F. Burke,Anita M. McGahan
Publisher : Springer
Page : 344 pages
File Size : 48,9 Mb
Release : 2015-07-28
Category : Medical
ISBN : 9781489975973

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Innovating for Healthy Urbanization by Roy Ahn,Thomas F. Burke,Anita M. McGahan Pdf

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.