Fda Issues

Author : Barry Leonard
Publisher : DIANE Publishing
Page : 476 pages
File Size : 45,7 Mb
Release : 2011-08
Category : Technology & Engineering
ISBN : 9781437987461

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Fish and Fishery Products by Barry Leonard Pdf

This guidance will assist processors of fish and fishery products in the development of their Hazard Analysis Critical Control Point (HACCP) plans. Processors of fish and fishery products will find info. that will help them identify hazards that are associated with their products, and help them formulate control strategies. It will help consumers understand commercial seafood safety in terms of hazards and their controls. It does not specifically address safe handling practices by consumers or by retail estab., although the concepts contained in this guidance are applicable to both. This guidance will serve as a tool to be used by fed. and state regulatory officials in the evaluation of HACCP plans for fish and fishery products. Illustrations. This is a print on demand report.

Author : Institute of Medicine,Committee to Study the Use of Advisory Committees
Publisher : National Academies Press
Page : 239 pages
File Size : 41,8 Mb
Release : 1992-02-01
Category : Medical
ISBN : 9780309048378

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Food and Drug Administration Advisory Committees by Institute of Medicine,Committee to Study the Use of Advisory Committees Pdf

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.

Author : Holly Fernandez Lynch,I. Glenn Cohen
Publisher : Columbia University Press
Page : 499 pages
File Size : 53,7 Mb
Release : 2015-09-08
Category : Business & Economics
ISBN : 9780231540070

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FDA in the Twenty-First Century by Holly Fernandez Lynch,I. Glenn Cohen Pdf

In its decades-long effort to assure the safety, efficacy, and security of medicines and other products, the Food and Drug Administration has struggled with issues of funding, proper associations with industry, and the balance between consumer choice and consumer protection. Today, these challenges are compounded by the pressures of globalization, the introduction of novel technologies, and fast-evolving threats to public health. With essays by leading scholars and government and private-industry experts, FDA in the Twenty-First Century addresses perennial and new problems and the improvements the agency can make to better serve the public good. The collection features essays on effective regulation in an era of globalization, consumer empowerment, and comparative effectiveness, as well as questions of data transparency, conflicts of interest, industry responsibility, and innovation policy, all with an emphasis on pharmaceuticals. The book also intervenes in the debate over off-label drug marketing and the proper role of the FDA before and after a drug goes on the market. Dealing honestly and thoroughly with the FDA's successes and failures, these essays rethink the structure, function, and future of the agency and the effect policy innovations may have on regulatory institutions abroad.

Author : National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Sciences Policy,Committee on Pain Management and Regulatory Strategies to Address Prescription Opioid Abuse
Publisher : National Academies Press
Page : 483 pages
File Size : 55,7 Mb
Release : 2017-09-28
Category : Medical
ISBN : 9780309459570

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Pain Management and the Opioid Epidemic by National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Sciences Policy,Committee on Pain Management and Regulatory Strategies to Address Prescription Opioid Abuse Pdf

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 : United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health and the Environment
Publisher : Unknown
Page : 808 pages
File Size : 50,5 Mb
Release : 1985
Category : Drugs
ISBN : STANFORD:36105045266421

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FDA Issues by United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health and the Environment Pdf

Author : Institute of Medicine,Board on Population Health and Public Health Practice,Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process
Publisher : National Academies Press
Page : 141 pages
File Size : 54,5 Mb
Release : 2010-10-04
Category : Medical
ISBN : 9780309162906

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Public Health Effectiveness of the FDA 510(k) Clearance Process by Institute of Medicine,Board on Population Health and Public Health Practice,Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process Pdf

The Food and Drug Administration (FDA) is responsible for assuring that medical devices are safe and effective before they go on the market. As part of its assessment of FDA's premarket clearance process for medical devices, the IOM held a workshop June 14-15 to discuss how to best balance patient safety and technological innovation. This document summarizes the workshop.

Author : Mark Walderhaug
Publisher : Createspace Independent Publishing Platform
Page : 292 pages
File Size : 51,6 Mb
Release : 2014-01-14
Category : Medical
ISBN : 1495203611

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Bad Bug Book by Mark Walderhaug Pdf

The Bad Bug Book 2nd Edition, released in 2012, provides current information about the major known agents that cause foodborne illness.Each chapter in this book is about a pathogen—a bacterium, virus, or parasite—or a natural toxin that can contaminate food and cause illness. The book contains scientific and technical information about the major pathogens that cause these kinds of illnesses.A separate “consumer box” in each chapter provides non-technical information, in everyday language. The boxes describe plainly what can make you sick and, more important, how to prevent it.The information provided in this handbook is abbreviated and general in nature, and is intended for practical use. It is not intended to be a comprehensive scientific or clinical reference.The Bad Bug Book is published by the Center for Food Safety and Applied Nutrition (CFSAN) of the Food and Drug Administration (FDA), U.S. Department of Health and Human Services.

Author : Institute of Medicine,Board on Population Health and Public Health Practice,Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process
Publisher : National Academies Press
Page : 318 pages
File Size : 50,5 Mb
Release : 2011-10-25
Category : Medical
ISBN : 9780309212458

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Medical Devices and the Public's Health by Institute of Medicine,Board on Population Health and Public Health Practice,Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process Pdf

Medical devices that are deemed to have a moderate risk to patients generally cannot go on the market until they are cleared through the FDA 510(k) process. In recent years, individuals and organizations have expressed concern that the 510(k) process is neither making safe and effective devices available to patients nor promoting innovation in the medical-device industry. Several high-profile mass-media reports and consumer-protection groups have profiled recognized or potential problems with medical devices cleared through the 510(k) clearance process. The medical-device industry and some patients have asserted that the process has become too burdensome and is delaying or stalling the entry of important new medical devices to the market. At the request of the FDA, the Institute of Medicine (IOM) examined the 510(k) process. Medical Devices and the Public's Health examines the current 510(k) clearance process and whether it optimally protects patients and promotes innovation in support of public health. It also identifies legislative, regulatory, or administrative changes that will achieve the goals of the 510(k) clearance process. Medical Devices and the Public's Health recommends that the U.S. Food and Drug Administration gather the information needed to develop a new regulatory framework to replace the 35-year-old 510(k) clearance process for medical devices. According to the report, the FDA's finite resources are best invested in developing an integrated premarket and postmarket regulatory framework.

Author : United States. General Accounting Office
Publisher : DIANE Publishing
Page : 157 pages
File Size : 43,8 Mb
Release : 1997
Category : Electronic
ISBN : 9781428977440

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Blood supply FDA oversight and remaining issues of safety : report to the ranking minority member, Committee on Commerce, House of Representatives. by United States. General Accounting Office Pdf

Author : Institute of Medicine,Board on Health Sciences Policy,Forum on Medical and Public Health Preparedness for Catastrophic Events
Publisher : National Academies Press
Page : 95 pages
File Size : 47,5 Mb
Release : 2010-12-16
Category : Medical
ISBN : 9780309186506

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Medical Countermeasures Dispensing by Institute of Medicine,Board on Health Sciences Policy,Forum on Medical and Public Health Preparedness for Catastrophic Events Pdf

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.

Author : Katherine Eban
Publisher : HarperCollins
Page : 512 pages
File Size : 47,6 Mb
Release : 2020-06-23
Category : Medical
ISBN : 9780063054103

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Bottle of Lies by Katherine Eban Pdf

A NEW YORK TIMES BESTSELLER New York Times 100 Notable Books of 2019 New York Public Library Best Books of 2019 Kirkus Reviews Best Health and Science Books of 2019 Science Friday Best Books of 2019 New postscript by the author From an award-winning journalist, an explosive narrative investigation of the generic drug boom that reveals fraud and life-threatening dangers on a global scale—The Jungle for pharmaceuticals Many have hailed the widespread use of generic drugs as one of the most important public-health developments of the twenty-first century. Today, almost 90 percent of our pharmaceutical market is comprised of generics, the majority of which are manufactured overseas. We have been reassured by our doctors, our pharmacists and our regulators that generic drugs are identical to their brand-name counterparts, just less expensive. But is this really true? Katherine Eban’s Bottle of Lies exposes the deceit behind generic-drug manufacturing—and the attendant risks for global health. Drawing on exclusive accounts from whistleblowers and regulators, as well as thousands of pages of confidential FDA documents, Eban reveals an industry where fraud is rampant, companies routinely falsify data, and executives circumvent almost every principle of safe manufacturing to minimize cost and maximize profit, confident in their ability to fool inspectors. Meanwhile, patients unwittingly consume medicine with unpredictable and dangerous effects. The story of generic drugs is truly global. It connects middle America to China, India, sub-Saharan Africa and Brazil, and represents the ultimate litmus test of globalization: what are the risks of moving drug manufacturing offshore, and are they worth the savings? A decade-long investigation with international sweep, high-stakes brinkmanship and big money at its core, Bottle of Lies reveals how the world’s greatest public-health innovation has become one of its most astonishing swindles.

Author : Institute of Medicine,Board on Population Health and Public Health Practice,Committee on Ethical and Scientific Issues in Studying the Safety of Approved Drugs
Publisher : National Academies Press
Page : 292 pages
File Size : 48,7 Mb
Release : 2012-07-30
Category : Medical
ISBN : 9780309218160

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Ethical and Scientific Issues in Studying the Safety of Approved Drugs by Institute of Medicine,Board on Population Health and Public Health Practice,Committee on Ethical and Scientific Issues in Studying the Safety of Approved Drugs Pdf

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.

Author : United States. General Accounting Office
Publisher : Unknown
Page : 12 pages
File Size : 47,6 Mb
Release : 2001
Category : Drugs
ISBN : UCBK:C079752088

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Drug Safety by United States. General Accounting Office Pdf

Author : Anonim
Publisher : Unknown
Page : 32 pages
File Size : 44,5 Mb
Release : 1995
Category : Food adulteration and inspection
ISBN : MINN:31951D01277485E

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The Food Defect Action Levels by Anonim Pdf

Author : Committee to Ensure Safe Food from Production to Consumption,Institute of Medicine,Board on Agriculture,Institute of Medicine and National Research Council
Publisher : National Academies Press
Page : 209 pages
File Size : 47,7 Mb
Release : 1998-09-02
Category : Medical
ISBN : 9780309593403

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Ensuring Safe Food by Committee to Ensure Safe Food from Production to Consumption,Institute of Medicine,Board on Agriculture,Institute of Medicine and National Research Council Pdf

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.