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Pathway to Global Product Safety and Quality

Author: Margaret A. Hamburg

Publisher: DIANE Publishing

Published: 2012-10-07

Total Pages: 37

ISBN-13: 1437988377

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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.

Book Synopsis Pathway to Global Product Safety and Quality by : Margaret A. Hamburg

Download or read book Pathway to Global Product Safety and Quality written by Margaret A. Hamburg and published by DIANE Publishing. This book was released on 2012-10-07 with total page 37 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Drugs

Author: Rick Ng

Publisher: John Wiley & Sons

Published: 2015-06-22

Total Pages: 554

ISBN-13: 1118907272

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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.

Book Synopsis Drugs by : Rick Ng

Download or read book Drugs written by Rick Ng and published by John Wiley & Sons. This book was released on 2015-06-22 with total page 554 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations for 2015

Author: United States. Congress. House. Committee on Appropriations. Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies

Publisher:

Published: 2014

Total Pages: 1096

ISBN-13:

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Book Synopsis 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

Download or read book Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations for 2015 written by United States. Congress. House. Committee on Appropriations. Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies and published by . This book was released on 2014 with total page 1096 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad

Author: Institute of Medicine

Publisher: National Academies Press

Published: 2012-09-03

Total Pages: 366

ISBN-13: 030922408X

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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.

Book Synopsis Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad by : Institute of Medicine

Download or read book Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad written by Institute of Medicine and published by National Academies Press. This book was released on 2012-09-03 with total page 366 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

The U.S. Healthcare System

Author: Joel I. Shalowitz

Publisher: John Wiley & Sons

Published: 2019-07-03

Total Pages: 720

ISBN-13: 1118418344

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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.

Book Synopsis The U.S. Healthcare System by : Joel I. Shalowitz

Download or read book The U.S. Healthcare System written by Joel I. Shalowitz and published by John Wiley & Sons. This book was released on 2019-07-03 with total page 720 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Review of the Proposed Generic Drug and Biosimilars User Fees and Further Examination of Drug Shortages

Author: United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health

Publisher:

Published: 2013

Total Pages: 212

ISBN-13:

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Book Synopsis 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

Download or read book Review of the Proposed Generic Drug and Biosimilars User Fees and Further Examination of Drug Shortages written by United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health and published by . This book was released on 2013 with total page 212 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Consumer Genetic Technologies

Author: I. Glenn Cohen

Publisher: Cambridge University Press

Published: 2021-09-16

Total Pages: 303

ISBN-13: 1108836615

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

Book Synopsis Consumer Genetic Technologies by : I. Glenn Cohen

Download or read book Consumer Genetic Technologies written by I. Glenn Cohen and published by Cambridge University Press. This book was released on 2021-09-16 with total page 303 pages. Available in PDF, EPUB and Kindle. Book excerpt: Examines the ethical, legal, and regulatory challenges presented as genomics become commonplace, easily available consumer products.

Food and Drug Regulation in an Era of Globalized Markets

Author: Sam F Halabi

Publisher: Academic Press

Published: 2015-08-31

Total Pages: 258

ISBN-13: 0128025506

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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

Book Synopsis Food and Drug Regulation in an Era of Globalized Markets by : Sam F Halabi

Download or read book Food and Drug Regulation in an Era of Globalized Markets written by Sam F Halabi and published by Academic Press. This book was released on 2015-08-31 with total page 258 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Securing the Pharmaceutical Supply Chain

Author: United States. Congress. Senate. Committee on Health, Education, Labor, and Pensions

Publisher:

Published: 2014

Total Pages: 96

ISBN-13:

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

Download or read book Securing the Pharmaceutical Supply Chain written by United States. Congress. Senate. Committee on Health, Education, Labor, and Pensions and published by . This book was released on 2014 with total page 96 pages. Available in PDF, EPUB and Kindle. Book excerpt:

The Multimedia Encyclopedia of Women in Today's World

Author: Mary Zeiss Stange

Publisher: SAGE Publications

Published: 2013-01-09

Total Pages: 1258

ISBN-13: 1452270686

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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.

Book Synopsis The Multimedia Encyclopedia of Women in Today's World by : Mary Zeiss Stange

Download or read book The Multimedia Encyclopedia of Women in Today's World written by Mary Zeiss Stange and published by SAGE Publications. This book was released on 2013-01-09 with total page 1258 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.