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 446 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Review Panel on New Drug Regulation 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 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 385 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 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 Drug regulation reform act of 1978 written by United States. Congress. House. Committee on Interstate and Foreign Commerce. Subcommittee on Health and the Environment and published by . This book was released on 1978 with total page 1422 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Ways of Regulating Drugs in the 19th and 20th Centuries written by Jean-Paul Gaudillière and published by Springer. This book was released on 2012-12-03 with total page 589 pages. Available in PDF, EPUB and Kindle. Book excerpt: This collection takes the perspective that the historiography of science, technology, and medicine needs a broader approach toward regulation. The authors explore the distinct social worlds involved in regulation, the forms of evidence and expertise mobilized, and means of intervention chosen to tame drugs in factories, consulting rooms and courts.
Download or read book Hearings Reports and Prints of the Senate Select Committee on Small Business written by United States. Congress. Senate. Select Committee on Small Business and published by . This book was released on 1980 with total page 830 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Review Panel on New Drug Regulation 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 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 Catalog of Publications written by United States. Department of Health, Education, and Welfare and published by . This book was released on 1976 with total page 710 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Publication Catalog of the U S Department of Health Education and Welfare written by United States. Dept. of Health, Education, and Welfare and published by . This book was released on 1978 with total page 696 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Publication Catalog of the U S Department of Health Education and Welfare written by United States. Department of Health, Education, and Welfare and published by . This book was released on 1977 with total page 700 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Publication Catalog of the U S Department of Health Education and Welfare written by United States. Department of Health, Education, and Welfare. Media and Publication Management Information Staff and published by . This book was released on with total page 696 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Federal Register written by and published by . This book was released on 1977 with total page 1246 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Review Panel on New Drug Regulation 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 Sharing Clinical Trial Data written by Institute of Medicine and published by National Academies Press. This book was released on 2015-04-20 with total page 236 pages. Available in PDF, EPUB and Kindle. Book excerpt: Data sharing can accelerate new discoveries by avoiding duplicative trials, stimulating new ideas for research, and enabling the maximal scientific knowledge and benefits to be gained from the efforts of clinical trial participants and investigators. At the same time, sharing clinical trial data presents risks, burdens, and challenges. These include the need to protect the privacy and honor the consent of clinical trial participants; safeguard the legitimate economic interests of sponsors; and guard against invalid secondary analyses, which could undermine trust in clinical trials or otherwise harm public health. Sharing Clinical Trial Data presents activities and strategies for the responsible sharing of clinical trial data. With the goal of increasing scientific knowledge to lead to better therapies for patients, this book identifies guiding principles and makes recommendations to maximize the benefits and minimize risks. This report offers guidance on the types of clinical trial data available at different points in the process, the points in the process at which each type of data should be shared, methods for sharing data, what groups should have access to data, and future knowledge and infrastructure needs. Responsible sharing of clinical trial data will allow other investigators to replicate published findings and carry out additional analyses, strengthen the evidence base for regulatory and clinical decisions, and increase the scientific knowledge gained from investments by the funders of clinical trials. The recommendations of Sharing Clinical Trial Data will be useful both now and well into the future as improved sharing of data leads to a stronger evidence base for treatment. This book will be of interest to stakeholders across the spectrum of research-from funders, to researchers, to journals, to physicians, and ultimately, to patients.
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 446 pages. Available in PDF, EPUB and Kindle. Book excerpt:
