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 Federal Regulation of Methadone Treatment written by Committee on Federal Regulation of Methadone Treatment and published by National Academies Press. This book was released on 1995-02-01 with total page 251 pages. Available in PDF, EPUB and Kindle. Book excerpt: For nearly three decades, methadone hydrochloride has been the primary means of treating opiate addiction. Today, about 115,000 people receive such treatment, and thousands more have benefited from it in the past. Even though methadone's effectiveness has been well established, its use remains controversial, a fact reflected by the extensive regulation of its manufacturing, labeling, distribution, and use. The Food and Drug Administration regulates the safety and effectiveness of methadone, as it does for all drugs, and the Drug Enforcement Administration regulates it as a controlled substance. However, methadone is also subjected to a unique additional tier of regulation that prescribes how and under what circumstances it may be used to treat opiate addiction. Federal Regulation of Methadone Treatment examines current Department of Health and Human Services standards for narcotic addiction treatment and the regulation of methadone treatment programs pursuant to those standards. The book includes an evaluation of the effect of federal regulations on the provision of methadone treatment services and an exploration of options for modifying the regulations to allow optimal clinical practice. The volume also includes an assessment of alternatives to the existing regulations.
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 444 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Final Report 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 212 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Review of the Food and Drug Administration s Handling of Adverse Drug Reaction Reports written by United States. Department of Health and Human Services. Office of Inspector General and published by . This book was released on 1999 with total page 25 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 Final Report 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 214 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Federal Control of New Drug Testing is Not Adequately Protecting Human Test Subjects and the Public Food and Drug Administration Department of Health Education and Welfare written by United States. General Accounting Office and published by . This book was released on 1976 with total page 108 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Challenges for the FDA written by Institute of Medicine and published by National Academies Press. This book was released on 2007-10-02 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.
Download or read book FDA Drug Bulletin written by and published by . This book was released on 1971 with total page 12 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Guideline for Postmarketing Reporting of Adverse Drug Reactions docket No 85D 0249 written by and published by . This book was released on 1985 with total page 52 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book General Considerations for the Clinical Evaluation of Drugs in Infants and Children written by United States. Food and Drug Administration. Bureau of Drugs and published by . This book was released on 1977 with total page 28 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Investigation of Allegations Relating to the Bureau of Drugs Food and Drug Administration 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 802 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Addressing the Barriers to Pediatric Drug Development written by Institute of Medicine and published by National Academies Press. This book was released on 2008-08-12 with total page 64 pages. Available in PDF, EPUB and Kindle. Book excerpt: Decades of research have demonstrated that children do not respond to medications in the same way as adults. Differences between children and adults in the overall response to medications are due to profound anatomical, physiological, and developmental differences. Although few would argue that children should receive medications that have not been adequately tested for safety and efficacy, the majority of drugs prescribed for children-50 to 75 percent-have not been tested in pediatric populations. Without adequate data from such testing, prescribing drugs appropriately becomes challenging for clinicians treating children, from infancy through adolescence. Addressing the Barriers to Pediatric Drug Development is the summary of a workshop, held in Washington, D.C. on June 13, 2006, that was organized to identify barriers to the development and testing of drugs for pediatric populations, as well as ways in which the system can be improved to facilitate better treatments for children.
Download or read book Federal Program Evaluations written by United States. General Accounting Office. Office of Program Analysis and published by . This book was released on 1976 with total page 908 pages. Available in PDF, EPUB and Kindle. Book excerpt: Contains an inventory of evaluation reports produced by and for selected Federal agencies, including GAO evaluation reports that relate to the programs of those agencies.
