Download or read book Answers to Questions on Selected FDA Bureau of Biologics Regulation Activities written by United States. General Accounting Office and published by . This book was released on 1980 with total page 84 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Answers to Questions on Selected FDA Bureau of Biologics Regulation Activities written by United States. General Accounting Office and published by . This book was released on 1980 with total page 75 pages. Available in PDF, EPUB and Kindle. Book excerpt: The efforts of the Food and Drug Administration (FDA), Bureau of Biologics to regulate vaccines and allergenic products were examined. The review was made in accordance with the provisions of the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act. Results of the review showed that the Bureau was limited by: (1) a relatively weak science base for understanding these products; (2) problems in conducting adequate and well-controlled clinical investigations on these products; and (3) the large number of products on the market.
Download or read book GAO Documents written by United States. General Accounting Office and published by . This book was released on 1981 with total page 916 pages. Available in PDF, EPUB and Kindle. Book excerpt: Catalog of reports, decisions and opinions, testimonies and speeches.
Download or read book Monthly Catalogue United States Public Documents written by and published by . This book was released on 1981 with total page 748 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Monthly Catalog of United States Government Publications written by and published by . This book was released on 1981 with total page 566 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Health bibliography written by and published by . This book was released on 1981 with total page 306 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book GAO documents written by United States. General Accounting Office and published by . This book was released on 1980 with total page 200 pages. Available in PDF, EPUB and Kindle. Book excerpt: Catalog of reports, decisions and opinions, testimonies and speeches.
Download or read book Food and Drug Law written by Richard M. Cooper and published by . This book was released on 1991 with total page 506 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Regulation of Biological Products written by National Institutes of Health (U.S.). Division of Biologics Standard and published by . This book was released on 1964 with total page 68 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 Safe and Effective Medicines for Children written by Institute of Medicine and published by National Academies Press. This book was released on 2012-10-13 with total page 432 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) were designed to encourage more pediatric studies of drugs used for children. The FDA asked the IOM to review aspects of pediatric studies and changes in product labeling that resulted from BPCA and PREA and their predecessor policies, as well as assess the incentives for pediatric studies of biologics and the extent to which biologics have been studied in children. The IOM committee concludes that these policies have helped provide clinicians who care for children with better information about the efficacy, safety, and appropriate prescribing of drugs. The IOM suggests that more can be done to increase knowledge about drugs used by children and thereby improve the clinical care, health, and well-being of the nation's children.
Download or read book A Bibliography of documents issued by the GAO on matters related to health written by United States. General Accounting Office and published by . This book was released on 1981* with total page 326 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Rare Diseases and Orphan Products written by Institute of Medicine and published by National Academies Press. This book was released on 2011-04-03 with total page 442 pages. Available in PDF, EPUB and Kindle. Book excerpt: Rare diseases collectively affect millions of Americans of all ages, but developing drugs and medical devices to prevent, diagnose, and treat these conditions is challenging. The Institute of Medicine (IOM) recommends implementing an integrated national strategy to promote rare diseases research and product development.
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 Small Clinical Trials written by Institute of Medicine and published by National Academies Press. This book was released on 2001-01-01 with total page 221 pages. Available in PDF, EPUB and Kindle. Book excerpt: Clinical trials are used to elucidate the most appropriate preventive, diagnostic, or treatment options for individuals with a given medical condition. Perhaps the most essential feature of a clinical trial is that it aims to use results based on a limited sample of research participants to see if the intervention is safe and effective or if it is comparable to a comparison treatment. Sample size is a crucial component of any clinical trial. A trial with a small number of research participants is more prone to variability and carries a considerable risk of failing to demonstrate the effectiveness of a given intervention when one really is present. This may occur in phase I (safety and pharmacologic profiles), II (pilot efficacy evaluation), and III (extensive assessment of safety and efficacy) trials. Although phase I and II studies may have smaller sample sizes, they usually have adequate statistical power, which is the committee's definition of a "large" trial. Sometimes a trial with eight participants may have adequate statistical power, statistical power being the probability of rejecting the null hypothesis when the hypothesis is false. Small Clinical Trials assesses the current methodologies and the appropriate situations for the conduct of clinical trials with small sample sizes. This report assesses the published literature on various strategies such as (1) meta-analysis to combine disparate information from several studies including Bayesian techniques as in the confidence profile method and (2) other alternatives such as assessing therapeutic results in a single treated population (e.g., astronauts) by sequentially measuring whether the intervention is falling above or below a preestablished probability outcome range and meeting predesigned specifications as opposed to incremental improvement.
Download or read book DPT a Shot in the Dark written by Harris Livermore Coulter and published by Houghton Mifflin Harcourt P. This book was released on 1985 with total page 486 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Government Reports Annual Index written by and published by . This book was released on 1988 with total page 1096 pages. Available in PDF, EPUB and Kindle. Book excerpt:
