Assessment of the Food and Drug Administration's Handling of Reports

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ISBN 13 :
Total Pages : 74 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Assessment of the Food and Drug Administration's Handling of Reports by : United States. General Accounting Office

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 74 pages. Available in PDF, EPUB and Kindle. Book excerpt:

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

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ISBN 13 :
Total Pages : 59 pages
Book Rating : 4.:/5 (11 download)

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Book Synopsis 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 by : United States. General Accounting Office

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:

Registries for Evaluating Patient Outcomes

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Publisher : Government Printing Office
ISBN 13 : 1587634333
Total Pages : 396 pages
Book Rating : 4.5/5 (876 download)

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Book Synopsis Registries for Evaluating Patient Outcomes by : Agency for Healthcare Research and Quality/AHRQ

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.

Assessment of the Food and Drug Administration's Handling of Reports

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ISBN 13 :
Total Pages : 68 pages
Book Rating : 4.:/5 (31 download)

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Book Synopsis Assessment of the Food and Drug Administration's Handling of Reports by : United States. General Accounting Office

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:

Managing the Risks from Medical Product Use

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ISBN 13 :
Total Pages : 24 pages
Book Rating : 4.:/5 (319 download)

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Book Synopsis Managing the Risks from Medical Product Use by : United States. Food and Drug Administration. Task Force on Risk Management

Download or read book Managing the Risks from Medical Product Use written by United States. Food and Drug Administration. Task Force on Risk Management and published by . This book was released on 1999 with total page 24 pages. Available in PDF, EPUB and Kindle. Book excerpt:

FDA Quarterly Activities Report

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ISBN 13 :
Total Pages : 816 pages
Book Rating : 4.F/5 ( download)

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Book Synopsis FDA Quarterly Activities Report by : United States. Food and Drug Administration. Program Information and Analysis Group

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 with total page 816 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Enhancing Food Safety

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Publisher : National Academies Press
ISBN 13 : 0309163587
Total Pages : 589 pages
Book Rating : 4.3/5 (91 download)

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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.

Annual Performance Report

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ISBN 13 :
Total Pages : 28 pages
Book Rating : 4.:/5 (3 download)

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Book Synopsis Annual Performance Report by : United States. Food and Drug Administration. Office of Management and Systems

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:

FDA Science and Mission at Risk

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Publisher : DIANE Publishing
ISBN 13 : 1437916414
Total Pages : 60 pages
Book Rating : 4.4/5 (379 download)

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Book Synopsis FDA Science and Mission at Risk by : Barry Leonard

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.

Medical Technology Assessment Directory

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Publisher : National Academies Press
ISBN 13 : 0309038294
Total Pages : 709 pages
Book Rating : 4.3/5 (9 download)

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Book Synopsis Medical Technology Assessment Directory by : Institute of Medicine

Download or read book Medical Technology Assessment Directory written by Institute of Medicine and published by National Academies Press. This book was released on 1988-02-01 with total page 709 pages. Available in PDF, EPUB and Kindle. Book excerpt: For the first time, a single reference identifies medical technology assessment programs. A valuable guide to the field, this directory contains more than 60 profiles of programs that conduct and report on medical technology assessments. Each profile includes a listing of report citations for that program, and all the reports are indexed under major subject headings. Also included is a cross-listing of technology assessment report citations arranged by type of technology headings, brief descriptions of approximately 70 information sources of potential interest to technology assessors, and addresses and descriptions of 70 organizations with memberships, activities, publications, and other functions relevant to the medical technology assessment community.

Challenges for the FDA

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Publisher : National Academies Press
ISBN 13 : 0309109868
Total Pages : 128 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Challenges for the FDA by : Institute of Medicine

Download or read book Challenges for the FDA written by Institute of Medicine and published by National Academies Press. This book was released on 2007-11-02 with total page 128 pages. Available in PDF, EPUB and Kindle. Book excerpt: As the principal agency regulating food, drugs, medical devices, and biological products used by Americans, the U.S. Food and Drug Administration (FDA) serves one of the most critical consumer protection functions of the federal government. The FDA's reach is enormous, regulating products that represent roughly 25 percent of all consumer spending in the United States. Since 1992, however, federal funding for the agency has diminished, and the FDA's Center for Drug Evaluation and Research (CDER) currently relies on the fees it receives from the industry it regulates to fund the majority of its drug regulation functions. Prescription drug safety is receiving heightened press coverage and congressional scrutiny as a result of recent, highly publicized events, such as the recall of Vioxx because of its link to heart attacks, and the link between certain antidepressants (selective serotonin reuptake inhibitors, or SSRIs) and an increased risk of suicidal ideation in children. To address these concerns, the FDA in 2005 commissioned the Institute of Medicine (IOM) to conduct an independent assessment of the current U.S. drug safety system. In September 2006, the IOM committee released its report-The Future of Drug Safety: Promoting and Protecting the Health of the Public-which included 25 recommendations for improving the system for drug safety review. The committee identified four major vulnerabilities in the U.S. drug safety system: (1) chronic underfunding; (2) organization problems, particularly inadequate integration of pre-and postmarket data review; (3) a range of technical problems related to the insufficient quantity and quality of postmarket data and inadequate capability to systematically monitor the risks and benefits of drugs after marketing; and (4) unclear regulatory authority and insufficiently flexible regulatory tools. Since the IOM report was issued, the FDA has taken a number of steps toward implementing the recommended improvements. Like many government agencies, however, the FDA is financially strained by its existing responsibilities, and fully implementing the recommended improvements to the drug safety system would require significant financial commitments.The IOM report addressed some of the costs associated with its recommendations, but left many unanswered questions about the resources required to fully achieve the envisioned improvements. To better understand the types and magnitude of resources required to achieve the goals of the IOM report, the IOM's Forum on Drug Discovery, Development, and Translation convened a 1-day symposium in March 2007. Challenges for the FDA: The Future of Drug Safety, Workshop Summary explains the presentations and discussions in seven key areas: addressing the FDA's resource challenges; strengthening the scientific base of the agency; integrating pre- and postmarket review; enhancing postmarket safety monitoring; conducting confirmatory drug safety and efficacy studies; enhancing the value of clinical trial registration; and enhancing the FDA's postmarket regulation and enforcement.

Annual Report - Food and Drug Administration

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ISBN 13 :
Total Pages : 1168 pages
Book Rating : 4.:/5 (319 download)

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Book Synopsis Annual Report - Food and Drug Administration by : United States. Food and Drug Administration

Download or read book Annual Report - Food and Drug Administration written by United States. Food and Drug Administration and published by . This book was released on 1950 with total page 1168 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Ensuring Safe Food

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Publisher : National Academies Press
ISBN 13 : 0309593409
Total Pages : 209 pages
Book Rating : 4.3/5 (95 download)

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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.

Report of the Federal Security Agency Food and Drug Administration

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ISBN 13 :
Total Pages : 1166 pages
Book Rating : 4.:/5 (311 download)

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Book Synopsis Report of the Federal Security Agency Food and Drug Administration by : United States. Food and Drug Administration

Download or read book Report of the Federal Security Agency Food and Drug Administration written by United States. Food and Drug Administration and published by . This book was released on 1949 with total page 1166 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Quantitative Evaluation of Safety in Drug Development

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Publisher : CRC Press
ISBN 13 : 1466555475
Total Pages : 374 pages
Book Rating : 4.4/5 (665 download)

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Book Synopsis Quantitative Evaluation of Safety in Drug Development by : Qi Jiang

Download or read book Quantitative Evaluation of Safety in Drug Development written by Qi Jiang and published by CRC Press. This book was released on 2014-12-08 with total page 374 pages. Available in PDF, EPUB and Kindle. Book excerpt: State-of-the-Art Methods for Drug Safety AssessmentResponding to the increased scrutiny of drug safety in recent years, Quantitative Evaluation of Safety in Drug Development: Design, Analysis and Reporting explains design, monitoring, analysis, and reporting issues for both clinical trials and observational studies in biopharmaceutical product deve

Final Report of the Advisory Committee on the Food and Drug Administration

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ISBN 13 :
Total Pages : 370 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Final Report of the Advisory Committee on the Food and Drug Administration by : United States. Department of Health and Human Services. Advisory Committee on the Food and Drug Administration

Download or read book Final Report of the Advisory Committee on the Food and Drug Administration written by United States. Department of Health and Human Services. Advisory Committee on the Food and Drug Administration and published by . This book was released on 1991 with total page 370 pages. Available in PDF, EPUB and Kindle. Book excerpt:

FDA Quarterly Activities Report

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ISBN 13 :
Total Pages : 338 pages
Book Rating : 4.E/5 ( download)

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Book Synopsis FDA Quarterly Activities Report by : United States. Food and Drug Administration

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: