Committee on Stronger Food and Drug Regulatory Systems Abroad's Books

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

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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

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.

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243

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National Academies Press

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ISBN 10

0309670438

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9780309670432

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

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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

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National Academies Press

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ISBN 10

0309670462

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9780309670463

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

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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

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.

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366

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National Academies Press

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ISBN 10

030922408X

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9780309224086

Regulating Medicines in a Globalized World

The Need for Increased Reliance Among Regulators

By: National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Global Health,Committee on Mutual Recognition Agreements and Reliance in the Regulation of Medicines

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Regulating Medicines in a Globalized World

The Need for Increased Reliance Among Regulators

Globalization is rapidly changing lives and industries around the world. Drug development, authorization, and regulatory supervision have become international endeavors, with most medicines becoming global commodities. Drug companies utilize global supply chains that often include facilities in countries with inconsistent regulations from those of the United States, perform pivotal trials in multiple countries to support registration submissions in various jurisdictions, and subsequently market their medicines throughout most of the world. These companies operate across borders and require individual national regulators to ensure that drugs authorized for use in their countries are safe and effective, and appropriate for their health care system and their population. This process involves significant resources and often duplicative work. It is important to consider how this process can be improved in order to better allocate resources, time, and efforts to improve public health. Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators considers the role of mutual recognition and other reliance activities among regulators in contributing to enhancing public health. This report identifies opportunities for leveraging reliance activities more broadly in order to potentially impact public health globally. Key topics in this report include the job of medicines regulators in today's world, what policy makers need to know about today's regulatory environment, stakeholder views of recognition and reliance, as well as removing impediments and facilitating action for greater recognition and reliance among regulatory authorities.

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169

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National Academies Press

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ISBN 10

030949866X

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9780309498661

Food and Drug Administration Advisory Committees

By: Institute of Medicine,Committee to Study the Use of Advisory Committees

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Food and Drug Administration Advisory Committees

By: Institute of Medicine,Committee to Study the Use of Advisory Committees

Like many other agencies of the federal government, the Food and Drug Administration (FDA) relies extensively on external advisory committees for independent scientific and technical advice. Recognizing that the existing advisory committee system is essentially sound, this volume recommends ways of enhancing the use of these committees in the evaluation of drugs, biological materials, and medical devices; strengthening the agency's management of the system; and increasing the accountability of the system to the public. In doing so, it examines and makes recommendations on such issues as the recruitment of committee members, the FDA's management of financial conflict of interest and intellectual bias among members, and the operations and management of the advisory committee system.

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239

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National Academies Press

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ISBN 10

0309048370

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9780309048378

Enhancing Food Safety

The Role of the Food and Drug Administration

By: National Research Council,Institute of Medicine,Board on Agriculture and Natural Resources,Food and Nutrition Board,Committee on the Review of the Food and Drug Administration's Role in Ensuring Safe Food

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Enhancing Food Safety

The Role of the Food and Drug Administration

Recent outbreaks of illnesses traced to contaminated sprouts and lettuce illustrate the holes that exist in the system for monitoring problems and preventing foodborne diseases. Although it is not solely responsible for ensuring the safety of the nation's food supply, the U.S. Food and Drug Administration (FDA) oversees monitoring and intervention for 80 percent of the food supply. The U.S. Food and Drug Administration's abilities to discover potential threats to food safety and prevent outbreaks of foodborne illness are hampered by impediments to efficient use of its limited resources and a piecemeal approach to gathering and using information on risks. Enhancing Food Safety: The Role of the Food and Drug Administration, a new book from the Institute of Medicine and the National Research Council, responds to a congressional request for recommendations on how to close gaps in FDA's food safety systems. Enhancing Food Safety begins with a brief review of the Food Protection Plan (FPP), FDA's food safety philosophy developed in 2007. The lack of sufficient detail and specific strategies in the FPP renders it ineffectual. The book stresses the need for FPP to evolve and be supported by the type of strategic planning described in these pages. It also explores the development and implementation of a stronger, more effective food safety system built on a risk-based approach to food safety management. Conclusions and recommendations include adopting a risk-based decision-making approach to food safety; creating a data surveillance and research infrastructure; integrating federal, state, and local government food safety programs; enhancing efficiency of inspections; and more. Although food safety is the responsibility of everyone, from producers to consumers, the FDA and other regulatory agencies have an essential role. In many instances, the FDA must carry out this responsibility against a backdrop of multiple stakeholder interests, inadequate resources, and competing priorities. Of interest to the food production industry, consumer advocacy groups, health care professionals, and others, Enhancing Food Safety provides the FDA and Congress with a course of action that will enable the agency to become more efficient and effective in carrying out its food safety mission in a rapidly changing world.

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588

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ISBN 10

0309152739

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9780309152730

Book's by Committee on Stronger Food and Drug Regulatory Systems Abroad

Stronger Food and Drug Regulatory Systems Abroad

Stronger Food and Drug Regulatory Systems Abroad

Stronger Food and Drug Regulatory Systems Abroad

Stronger Food and Drug Regulatory Systems Abroad

Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad

Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad

Regulating Medicines in a Globalized World

Regulating Medicines in a Globalized World

Food and Drug Administration Advisory Committees

Food and Drug Administration Advisory Committees

Enhancing Food Safety

Enhancing Food Safety

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