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The Adequacy Of Fda To Assure The Safety Of The Nations Drug Supply
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Author :United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Oversight and Investigations Publisher : ISBN 13 : Total Pages :324 pages Book Rating :4.0/5 ( download)
Book Synopsis The Adequacy of FDA to Assure the Safety of the Nation's Drug Supply by : United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Oversight and Investigations
Download or read book The Adequacy of FDA to Assure the Safety of the Nation's Drug Supply written by United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Oversight and Investigations and published by . This book was released on 2007 with total page 324 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Adequacy of FDA to Assure the Safety of the Nation’s Drug Supply: Congressional Hearing by :
Download or read book Adequacy of FDA to Assure the Safety of the Nation’s Drug Supply: Congressional Hearing written by and published by DIANE Publishing. This book was released on with total page 326 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Enhancing Food Safety by : National Research Council
Download or read book Enhancing Food Safety written by National Research Council and published by National Academies Press. This book was released on 2010-11-04 with total page 589 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Author :National Academies of Sciences, Engineering, and Medicine Publisher :National Academies Press ISBN 13 :0309459575 Total Pages :483 pages Book Rating :4.3/5 (94 download)
Book Synopsis Pain Management and the Opioid Epidemic by : National Academies of Sciences, Engineering, and Medicine
Download or read book Pain Management and the Opioid Epidemic written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2017-09-28 with total page 483 pages. Available in PDF, EPUB and Kindle. Book excerpt: Drug overdose, driven largely by overdose related to the use of opioids, is now the leading cause of unintentional injury death in the United States. The ongoing opioid crisis lies at the intersection of two public health challenges: reducing the burden of suffering from pain and containing the rising toll of the harms that can arise from the use of opioid medications. Chronic pain and opioid use disorder both represent complex human conditions affecting millions of Americans and causing untold disability and loss of function. In the context of the growing opioid problem, the U.S. Food and Drug Administration (FDA) launched an Opioids Action Plan in early 2016. As part of this plan, the FDA asked the National Academies of Sciences, Engineering, and Medicine to convene a committee to update the state of the science on pain research, care, and education and to identify actions the FDA and others can take to respond to the opioid epidemic, with a particular focus on informing FDA's development of a formal method for incorporating individual and societal considerations into its risk-benefit framework for opioid approval and monitoring.
Author :Committee to Ensure Safe Food from Production to Consumption Publisher :National Academies Press ISBN 13 :0309593409 Total Pages :209 pages Book Rating :4.3/5 (95 download)
Book Synopsis Ensuring Safe Food by : Committee to Ensure Safe Food from Production to Consumption
Download or read book Ensuring Safe Food written by Committee to Ensure Safe Food from Production to Consumption and published by National Academies Press. This book was released on 1998-09-02 with total page 209 pages. Available in PDF, EPUB and Kindle. Book excerpt: How safe is our food supply? Each year the media report what appears to be growing concern related to illness caused by the food consumed by Americans. These food borne illnesses are caused by pathogenic microorganisms, pesticide residues, and food additives. Recent actions taken at the federal, state, and local levels in response to the increase in reported incidences of food borne illnesses point to the need to evaluate the food safety system in the United States. This book assesses the effectiveness of the current food safety system and provides recommendations on changes needed to ensure an effective science-based food safety system. Ensuring Safe Food discusses such important issues as: What are the primary hazards associated with the food supply? What gaps exist in the current system for ensuring a safe food supply? What effects do trends in food consumption have on food safety? What is the impact of food preparation and handling practices in the home, in food services, or in production operations on the risk of food borne illnesses? What organizational changes in responsibility or oversight could be made to increase the effectiveness of the food safety system in the United States? Current concerns associated with microbiological, chemical, and physical hazards in the food supply are discussed. The book also considers how changes in technology and food processing might introduce new risks. Recommendations are made on steps for developing a coordinated, unified system for food safety. The book also highlights areas that need additional study. Ensuring Safe Food will be important for policymakers, food trade professionals, food producers, food processors, food researchers, public health professionals, and consumers.
Book Synopsis Diminished Capacity: Can the FDA Assure the Safety and Security of the Nation's Food Supply? Serial No. 110-33 Part A, April 24 and July 17, 2007, 110-1 Hearings, * by :
Download or read book Diminished Capacity: Can the FDA Assure the Safety and Security of the Nation's Food Supply? Serial No. 110-33 Part A, April 24 and July 17, 2007, 110-1 Hearings, * written by and published by . This book was released on 2009 with total page 826 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Ethical and Scientific Issues in Studying the Safety of Approved Drugs by : Institute of Medicine
Download or read book Ethical and Scientific Issues in Studying the Safety of Approved Drugs written by Institute of Medicine and published by National Academies Press. This book was released on 2012-07-30 with total page 292 pages. Available in PDF, EPUB and Kindle. Book excerpt: An estimated 48 percent of the population takes at least one prescription drug in a given month. Drugs provide great benefits to society by saving or improving lives. Many drugs are also associated with side effects or adverse events, some serious and some discovered only after the drug is on the market. The discovery of new adverse events in the postmarketing setting is part of the normal natural history of approved drugs, and timely identification and warning about drug risks are central to the mission of the Food and Drug Administration (FDA). Not all risks associated with a drug are known at the time of approval, because safety data are collected from studies that involve a relatively small number of human subjects during a relatively short period. Written in response to a request by the FDA, Ethical and Scientific Issues in Studying the Safety of Approved Drugs discusses ethical and informed consent issues in conducting studies in the postmarketing setting. It evaluates the strengths and weaknesses of various approaches to generate evidence about safety questions, and makes recommendations for appropriate followup studies and randomized clinical trials. The book provides guidance to the FDA on how it should factor in different kinds of evidence in its regulatory decisions. Ethical and Scientific Issues in Studying the Safety of Approved Drugs will be of interest to the pharmaceutical industry, patient advocates, researchers, and consumer groups.
Book Synopsis Food and Drug Administration Advisory Committees by : Institute of Medicine
Download or read book Food and Drug Administration Advisory Committees written by Institute of Medicine and published by National Academies Press. This book was released on 1992-02-01 with total page 239 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
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.
Book Synopsis Examining the Implications of Drug Importation by : United States. Congress. Senate. Committee on the Judiciary
Download or read book Examining the Implications of Drug Importation written by United States. Congress. Senate. Committee on the Judiciary and published by . This book was released on 2008 with total page 294 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author :United States. Public Health Service. Division of Environmental Engineering and Food Protection Publisher : ISBN 13 : Total Pages :32 pages Book Rating :4.E/5 ( download)
Book Synopsis The Vending of Food and Beverages by : United States. Public Health Service. Division of Environmental Engineering and Food Protection
Download or read book The Vending of Food and Beverages written by United States. Public Health Service. Division of Environmental Engineering and Food Protection and published by . This book was released on 1965 with total page 32 pages. Available in PDF, EPUB and Kindle. Book excerpt: Recommendations developed by the Public Health Service in cooperation with state and communities, interested federal agencies and the vending machine industry, 1965.
Book Synopsis Freedom to Harm by : Thomas O. McGarity
Download or read book Freedom to Harm written by Thomas O. McGarity and published by Yale University Press. This book was released on 2013-03-19 with total page 519 pages. Available in PDF, EPUB and Kindle. Book excerpt: DIV How much economic freedom is a good thing? This book tells the story of how the business community, and the trade associations and think tanks that it created, launched three powerful assaults during the last quarter of the twentieth century on the federal regulatory system and the state civil justice system to accomplish a revival of the laissez faire political economy that dominated Gilded Age America. Although the consequences of these assaults became painfully apparent in a confluence of crises during the early twenty-first century, the patch-and-repair fixes that Congress and the Obama administration put into place did little to change the underlying laissez faire ideology and practice that continues to dominate the American political economy. In anticipation of the next confluence of crises, Thomas McGarity offers suggestions for more comprehensive governmental protections for consumers, workers, and the environment. /div
Book Synopsis Groupthink in Science by : David M. Allen
Download or read book Groupthink in Science written by David M. Allen and published by Springer Nature. This book was released on 2020-04-23 with total page 285 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book discusses one of the hottest topics in science today, i.e., the concern over certain problematic practices within the scientific enterprise. It raises questions and, more importantly, begins to supply answers about one particularly widespread phenomenon that sometimes impedes scientific progress: group processes. The book looks at many problematic manifestations of “going along with the crowd” that are adopted at the expense of truth. Closely related is the concept of pathological altruism or altruism bias—the tendency of scientists to bias their research in order to further the ideological or financial interests of an “in-group” at the expense of both the interest of other groups as well as the truth. The book challenges the widespread notion that science is invariably a benevolent, benign process. It defines the scientific enterprise, in practice as opposed to in theory, as a cultural system designed to produce factual knowledge. In effect, the book offers a broad and unique take on an important and incompletely explored subject: research and academic discourse that sacrifices scientific objectivity, and perhaps even the scientist’s own ethical standards, in order to further the goals of a particular group of researchers or reinforce their shared belief system or their own interests, whether economic, ideological, or bureaucratic.
Book Synopsis Medical Countermeasures Dispensing by : Institute of Medicine
Download or read book Medical Countermeasures Dispensing written by Institute of Medicine and published by National Academies Press. This book was released on 2010-12-16 with total page 95 pages. Available in PDF, EPUB and Kindle. Book excerpt: During public health emergencies such as terrorist attacks or influenza outbreaks, the public health system's ability to save lives could depend on dispensing medical countermeasures such as antibiotics, antiviral medications, and vaccines to a large number of people in a short amount of time. The IOM's Forum on Medical and Public Health Preparedness for Catastrophic Events held a workshop on November 18, 2009, to provide an overview of current threats, recent progress made in the public health system for distributing and dispensing countermeasures, and remaining vulnerabilities.
Book Synopsis Enhancing the Regulatory Decision-Making Approval Process for Direct Food Ingredient Technologies by : Institute of Medicine
Download or read book Enhancing the Regulatory Decision-Making Approval Process for Direct Food Ingredient Technologies written by Institute of Medicine and published by National Academies Press. This book was released on 1999-04-29 with total page 158 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Institute of Medicine's (IOM's) Food Forum was established in 1993 to allow science and technology leaders in the food industry, top administrators in the federal government, representatives from consumer interest groups, and academicians to discuss and debate food and food safety issues openly and in a neutral setting. The Forum provides a mechanism for these diverse groups to identify possible approaches for addressing food and food safety problems and issues surrounding the often complex interactions among industry, academia, regulatory agencies, and consumers. On May 6-7, 1997, the Forum convened a workshop titled Enhancing the Regulatory Decision-Making Process for Direct Food Ingredient Technologies. Workshop speakers and participants discussed legal aspects of the direct food additive approval process, changes in science and technology, and opportunities for reform. Two background papers, which can be found in Appendix A and B, were shared with the participants prior to the workshop. The first paper provided a description and history of the legal framework of the food ingredient approval process and the second paper focused on changes in science and technology practices with emphasis placed on lessons learned from case studies. This document presents a summary of the workshop.
Author :United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Oversight and Investigations Publisher : ISBN 13 : Total Pages :830 pages Book Rating :4.0/5 ( download)
Book Synopsis Diminished Capacity by : United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Oversight and Investigations
Download or read book Diminished Capacity written by United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Oversight and Investigations and published by . This book was released on 2008 with total page 830 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Until There's a Cure by : United States. Congress. Senate. Special Committee on Aging
Download or read book Until There's a Cure written by United States. Congress. Senate. Special Committee on Aging and published by . This book was released on 2011 with total page 224 pages. Available in PDF, EPUB and Kindle. Book excerpt:
