Download or read book Assessment of the Food and Drug Administration s Handling of Reports written by United States. General Accounting Office and published by . This book was released on 1974 with total page 68 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Assessment of the Food and Drug Administration s Handling of Reports on Adverse Reactions from the Use of Drugs Department of Health Education and Welfare written by United States. General Accounting Office and published by . This book was released on 1974 with total page 59 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Registries for Evaluating Patient Outcomes written by Agency for Healthcare Research and Quality/AHRQ and published by Government Printing Office. This book was released on 2014-04-01 with total page 396 pages. Available in PDF, EPUB and Kindle. Book excerpt: This User’s Guide is intended to support the design, implementation, analysis, interpretation, and quality evaluation of registries created to increase understanding of patient outcomes. For the purposes of this guide, a patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes. A registry database is a file (or files) derived from the registry. Although registries can serve many purposes, this guide focuses on registries created for one or more of the following purposes: to describe the natural history of disease, to determine clinical effectiveness or cost-effectiveness of health care products and services, to measure or monitor safety and harm, and/or to measure quality of care. Registries are classified according to how their populations are defined. For example, product registries include patients who have been exposed to biopharmaceutical products or medical devices. Health services registries consist of patients who have had a common procedure, clinical encounter, or hospitalization. Disease or condition registries are defined by patients having the same diagnosis, such as cystic fibrosis or heart failure. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews.
Download or read book Annual Performance Report written by United States. Food and Drug Administration. Office of Management and Systems and published by . This book was released on 1997 with total page 28 pages. Available in PDF, EPUB and Kindle. Book excerpt:
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.
Download or read book Annual Performance Report written by United States. Food and Drug Administration. Office of Management and Systems and published by . This book was released on 1998 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book FDA Science and Mission at Risk written by Barry Leonard and published by DIANE Publishing. This book was released on 2009-12 with total page 60 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Food and Drug Admin. (FDA¿s) responsibilities for protecting the health of Americans are far-reaching. This report assesses whether FDA¿s current science and technology was sufficient to protect the nation¿s food and drug supply. The FDA Science Board undertook this review and included outside experts from industry, academia, and other gov¿t. agencies. The report, more than a year in the making, is one of the most comprehensive examinations of the FDA in its history. It concludes that the FDA cannot fulfill its mission because: its scientific base has eroded and its scientific organizational structure is weak; its scientific workforce does not have sufficient capacity and capability; and its information technology infrastructure is inadequate.
Download or read book Interim Reports written by United States. Department of Health, Education, and Welfare. Review Panel on New Drug Regulation and published by . This book was released on 1977 with total page 576 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book FDA Quarterly Activities Report written by United States. Food and Drug Administration. Program Information and Analysis Group and published by . This book was released on 1977 with total page 76 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Bacteriological Analytical Manual written by United States. Food and Drug Administration. Division of Microbiology and published by . This book was released on 1969 with total page 180 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book FDA Quarterly Activities Report written by United States. Food and Drug Administration and published by . This book was released on 1970 with total page 338 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Review Panel on New Drug Regulation Interim Reports written by United States. Department of Health, Education, and Welfare. Review Panel on New Drug Regulation and published by . This book was released on 1977 with total page 580 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Annual Report 1972 written by United States. Food and Drug Administration and published by . This book was released on 1975 with total page 91 pages. Available in PDF, EPUB and Kindle. Book excerpt:
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.
Download or read book Fish and Fishery Products written by Barry Leonard and published by DIANE Publishing. This book was released on 2011-08 with total page 476 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Interim Reports written by United States. Dept. of Health, Education, and Welfare. Review Panel on New Drug Regulation and published by . This book was released on 1977 with total page 380 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Food and Drug Administration Laboratory Analysis of Product Samples Needs to be More Timely written by United States. General Accounting Office and published by . This book was released on 1986 with total page 72 pages. Available in PDF, EPUB and Kindle. Book excerpt: A primary responsibility of the Food and Drug Administration (FDA) is to protect the American consumer from adulterated or misbranded (violative) products. The role of FDA's field laboratories in accomplishing this mission is critical. They test numerous samples of products for possible violations. When violative products are identified, FDA takes regulatory actions, including seizures, to remove them from the market. Removing violative products from the market through seizure takes time. As the time frame for action increases, so does the amount of violative products reaching the consumer. This report discusses (1) the timeliness of field laboratories in processing product samples to determine if they are violative and (2) measures that can be implemented to bring about improvements.
