Review Panel on New Drug Regulation : Interim Reports PDF Download

Author: United States. Department of Health, Education, and Welfare. Review Panel on New Drug Regulation
Publisher:
ISBN:
Category : Drugs
Languages : en
Pages : 446

View

Book Description

Author: United States. Department of Health, Education, and Welfare. Review Panel on New Drug Regulation
Publisher:
ISBN:
Category : Drugs
Languages : en
Pages : 214

View

Book Description

Author: United States. Department of Health, Education, and Welfare. Review Panel on New Drug Regulation
Publisher:
ISBN:
Category : Drugs
Languages : en
Pages : 580

View

Book Description

Author: Agency for Healthcare Research and Quality/AHRQ
Publisher: Government Printing Office
ISBN: 1587634333
Category : Medical
Languages : en
Pages : 385

View

Book Description
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.

Author: United States. Congress. House. Committee on Interstate and Foreign Commerce. Subcommittee on Health and the Environment
Publisher:
ISBN:
Category :
Languages : en
Pages : 1422

View

Book Description

Author: Jean-Paul Gaudillière
Publisher: Springer
ISBN: 1137291524
Category : History
Languages : en
Pages : 589

View

Book Description
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.

Author: United States. Congress. Senate. Select Committee on Small Business
Publisher:
ISBN:
Category : Legislative hearings
Languages : en
Pages : 830

View

Book Description

Author: United States. Department of Health, Education, and Welfare. Review Panel on New Drug Regulation
Publisher:
ISBN:
Category : Drugs
Languages : en
Pages :

View

Book Description

Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 0309459575
Category : Medical
Languages : en
Pages : 483

View

Book Description
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.

Author: United States. Department of Health, Education, and Welfare
Publisher:
ISBN:
Category : Charities
Languages : en
Pages : 710

View

Book Description