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Author : United States. Congress. House. Committee on Government Operations
Publisher : Unknown
Page : 20 pages
File Size : 43,8 Mb
Release : 1971
Category : Food law and legislation
ISBN : LCCN:75614978
Author : United States. Congress. House. Committee on Government Operations. Intergovernmental Relations Subcommittee
Publisher : Unknown
Page : 108 pages
File Size : 42,8 Mb
Release : 1971
Category : Food contamination
ISBN : LOC:0018430126A
Author : Anonim
Publisher : Unknown
Page : 556 pages
File Size : 43,6 Mb
Release : 2004
Category : Drugs
ISBN : MINN:31951D024617208
Author : Institute of Medicine,Committee to Study HIV Transmission Through Blood and Blood Products
Publisher : National Academies Press
Page : 349 pages
File Size : 51,5 Mb
Release : 1995-10-05
Category : Medical
ISBN : 9780309053297
During the early years of the AIDS epidemic, thousands of Americans became infected with HIV through the nation's blood supply. Because little reliable information existed at the time AIDS first began showing up in hemophiliacs and in others who had received transfusions, experts disagreed about whether blood and blood products could transmit the disease. During this period of great uncertainty, decision-making regarding the blood supply became increasingly difficult and fraught with risk. This volume provides a balanced inquiry into the blood safety controversy, which involves private sexual practices, personal tragedy for the victims of HIV/AIDS, and public confidence in America's blood services system. The book focuses on critical decisions as information about the danger to the blood supply emerged. The committee draws conclusions about what was doneâ€"and recommends what should be done to produce better outcomes in the face of future threats to blood safety. The committee frames its analysis around four critical area: Product treatmentâ€"Could effective methods for inactivating HIV in blood have been introduced sooner? Donor screening and referralâ€"including a review of screening to exlude high-risk individuals. Regulations and recall of contaminated bloodâ€"analyzing decisions by federal agencies and the private sector. Risk communicationâ€"examining whether infections could have been averted by better communication of the risks.
Author : Barry Leonard
Publisher : DIANE Publishing
Page : 476 pages
File Size : 44,8 Mb
Release : 2011-08
Category : Technology & Engineering
ISBN : 9781437987461
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,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 : 132 pages
File Size : 54,9 Mb
Release : 2011-06-10
Category : Medical
ISBN : 9780309162067
The Food and Drug Administration (FDA) is responsible for ensuring that medical devices are safe and effective before they go on the market. Section 510(k) of the Federal Food, Drug, and Cosmetic Act requires a manufacturer of medical devices to notify FDA of its intent to market a medical device at least 90 days in advance. That window of time allows FDA to evaluate whether the device is substantially equivalent to a product already legally on the market (called a predicate), in which case the device does not need to go through the premarket approval (PMA) process. As part of its assessment of the FDA's premarket clearance process for medical devices, the Institute of Medicine (IOM) held a workshop on July 28, 2010 to discuss how medical devices are monitored for safety after they are available to consumers. Its primary focus was on monitoring the safety of marketed medical devices, including FDA's postmarket surveillance activities, analysis of safety concerns that resulted in medical device recalls, and non-FDA sources of adverse-event information. Public Health Effectiveness of the FDA 501(K) Clearance Process summarizes the views of the workshop participants.
Author : 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
Publisher : National Academies Press
Page : 589 pages
File Size : 54,6 Mb
Release : 2010-11-04
Category : Medical
ISBN : 9780309163583
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 : Anonim
Publisher : Unknown
Page : 32 pages
File Size : 41,9 Mb
Release : 1995
Category : Food adulteration and inspection
ISBN : MINN:31951D01277485E
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 : 48,6 Mb
Release : 2017-09-28
Category : Medical
ISBN : 9780309459570
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 : Anonim
Publisher : Unknown
Page : 48 pages
File Size : 47,6 Mb
Release : 2014-01-01
Category : Law
ISBN : 0314291849
There has been a noticeable uptick in the number of food and beverage recalls in the past few years, made even more conspicuous due to how quickly information spreads online. With the additional scrutiny, it becomes increasingly important for companies to focus on risk management and response strategies. To that effect, a comprehensive understanding of recalls is crucial. What are some of the most common reasons for recalls? What are the different recall classifications? Whose responsibility is it to issue a recall? Does the FDA provide any guidance on the proper steps to take? What are the most common mistakes made during the food and drug recall process? How can they be avoided? How can companies minimize the fallout that occurs when a product is recalled? Going forward, what risk management strategies are most effective? Understanding Food and Beverage Recalls provides feedback from some of the nations leading legal minds on all aspects of the recall process, from initiation to damage control. These experts give insight into common questions and misconceptions regarding food and beverage recalls, and share their best practices for keeping up-to-date on FDA developments and overcoming challenges associated with upcoming changes. Additionally, the authors discuss recent noteworthy cases and successful defense strategies. This report offers readers an in-depth look at these issues as they continue to unfold.
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 : 46,9 Mb
Release : 2011-10-25
Category : Medical
ISBN : 9780309212458
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 : Food and Drug Administration
Publisher : Unknown
Page : 0 pages
File Size : 54,6 Mb
Release : 2003
Category : Drugs
ISBN : 0865879737
Available now to FDA-regulated organizations, this manual allows facility managers to look at their operation's regulatory compliance through the eyes of the government. Because this is the primary reference manual used by FDA personnel to conduct field investigation activities, you can feel confident you are preparing appropriate planning or action. This manual includes revised instructions regarding the release of information and covers FDA's policies and expectations on a comprehensive range of topics: FDA's authority to enter and inspect, inspection notification, detailed inspection procedures, recall monitoring, inspecting import procedures, computerized data requests, federal/state inspection relationships, discussions with management regarding privileged information, seizure and prosecution, HACCP, bioengineered food, dietary supplements, cosmetics, bioterrorism, and product disposition. The manual also includes a directory of Office of Regulatory Affairs offices and divisions.
Author : United States. General Accounting Office
Publisher : Unknown
Page : 40 pages
File Size : 45,6 Mb
Release : 1975
Category : Cardiac pacemakers
ISBN : SRLF:D0000178244
Author : Institute of Medicine,Board on Health Sciences Policy,Committee on Postmarket Surveillance of Pediatric Medical Devices
Publisher : National Academies Press
Page : 481 pages
File Size : 52,6 Mb
Release : 2006-01-20
Category : Medical
ISBN : 9780309096317
Innovative medical devices have helped reduce the burden of illness and injury and improve the quality of life for countless children. Mechanical ventilators and other respiratory support devices rescue thousands of fragile newborns every year. Children who once would have died of congenital heart conditions survive with the aid of implanted pacemakers, mechanical heart valves, and devices that close holes in the heart. Responding to a Congressional request, the Institute of Medicine assesses the system for postmarket surveillance of medical devices used with children. The book specifically examines: The Food and Drug Administration's monitoring and use of adverse event reports The agency's monitoring of manufacturers' fulfillment of commitments for postmarket studies ordered at the time of a device's approval for marketing The adequacy of postmarket studies of implanted devices to evaluate the effects of children's active lifestyles and their growth and development on device performance Postmarket surveillance of medical devices used with children is a little investigated topic, in part because the market for most medical products is concentrated among older adults. Yet children differ from adults, and their special characteristics have implications for evaluation and monitoring of the short- and long-term safety and effectiveness of medical devices used with young patients.
Author : United States. Federal Trade Commission. Bureau of Consumer Protection
Publisher : Unknown
Page : 32 pages
File Size : 41,6 Mb
Release : 1998
Category : Advertising
ISBN : UIUC:30112004816200