Drug Enforcement Administrations Regulation Of Medicine
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Author | : National Academies of Sciences, Engineering, and Medicine |
Publisher | : National Academies Press |
Total Pages | : 483 |
Release | : 2017-09-28 |
Genre | : Medical |
ISBN | : 0309459575 |
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 | : Institute of Medicine |
Publisher | : National Academies Press |
Total Pages | : 318 |
Release | : 2011-11-25 |
Genre | : Medical |
ISBN | : 0309212421 |
Medical devices that are deemed to have a moderate risk to patients generally cannot go on the market until they are cleared through the FDA 510(k) process. In recent years, individuals and organizations have expressed concern that the 510(k) process is neither making safe and effective devices available to patients nor promoting innovation in the medical-device industry. Several high-profile mass-media reports and consumer-protection groups have profiled recognized or potential problems with medical devices cleared through the 510(k) clearance process. The medical-device industry and some patients have asserted that the process has become too burdensome and is delaying or stalling the entry of important new medical devices to the market. At the request of the FDA, the Institute of Medicine (IOM) examined the 510(k) process. Medical Devices and the Public's Health examines the current 510(k) clearance process and whether it optimally protects patients and promotes innovation in support of public health. It also identifies legislative, regulatory, or administrative changes that will achieve the goals of the 510(k) clearance process. Medical Devices and the Public's Health recommends that the U.S. Food and Drug Administration gather the information needed to develop a new regulatory framework to replace the 35-year-old 510(k) clearance process for medical devices. According to the report, the FDA's finite resources are best invested in developing an integrated premarket and postmarket regulatory framework.
Author | : Institute of Medicine |
Publisher | : National Academies Press |
Total Pages | : 288 |
Release | : 1999-07-10 |
Genre | : Medical |
ISBN | : 0309071550 |
The medical use of marijuana is surrounded by a cloud of social, political, and religious controversy, which obscures the facts that should be considered in the debate. This book summarizes what we know about marijuana from evidence-based medicineâ€"the harm it may do and the relief it may bring to patients. The book helps the reader understand not only what science has to say about medical marijuana but also the logic behind the scientific conclusions. Marijuana and Medicine addresses the science base and the therapeutic effects of marijuana use for medical conditions such as glaucoma and multiple sclerosis. It covers marijuana's mechanism of action, acute and chronic effects on health and behavior, potential adverse effects, efficacy of different delivery systems, analysis of the data about marijuana as a gateway drug, and the prospects for developing cannabinoid drugs. The book evaluates how well marijuana meets accepted standards for medicine and considers the conclusions of other blue-ribbon panels. Full of useful facts, this volume will be important to anyone interested in informed debate about the medical use of marijuana: advocates and opponents as well as policymakers, regulators, and health care providers.
Author | : |
Publisher | : DIANE Publishing |
Total Pages | : 380 |
Release | : 1993 |
Genre | : Medical |
ISBN | : 9780788104688 |
Analyzes the costs, risks, and economic rewards of pharmaceutical R&D and the impact of public policy on both costs and returns. Examines the rapid increase in pharmaceutical R&D that began in the 1980s in the light of trends in science, technology, drug discovery, and health insurance coverage; Government regulation; product liability; market competition; Federal tax policy; and Federal support of prescription drug research. 12 appendices, including a glossary of terms.
Author | : |
Publisher | : |
Total Pages | : 256 |
Release | : 1992 |
Genre | : |
ISBN | : |
Author | : Eunjoo Pacifici |
Publisher | : Academic Press |
Total Pages | : 292 |
Release | : 2018-06-13 |
Genre | : Medical |
ISBN | : 0128111569 |
Today's challenge, especially for many newcomers to the regulated industry, is not necessarily to gather regulatory information, but to know how to interpret and apply it. The ability to discern what is important from what is not, and to interpret regulatory documents correctly, provides a valuable competitive advantage to any newcomer or established professional in this field. An Overview of FDA Regulated Products: From Drugs and Medical Devices to Food and Tobacco provides a valuable summary of the key information to unveil the meaning of critical, and often complex, regulatory concepts. Concise and easy to read with practical explanations, key points, summaries and case studies, this book highlights the regulatory processes involved in bringing an FDA regulated product from research and development to approval and market. Although the primary focus will be on the US system, this book also features global perspectives where appropriate. A valuable resource for students, professors and professionals, An Overview of FDA Regulated Products illustrates the most important elements and concepts so that the reader can focus on the critical issues and make the necessary connections to be successful. - Provides an overview of key regulatory requirements using a practical approach that features detailed discussions of hypothetical and real-world case studies in order to highlight the concepts and applications of regulations - Covers all FDA regulated products, including drugs, biologics, medical devices, cosmetics, foods, dietary supplements, cosmetics, veterinary products, tobacco and more in one single reference - Illustrates complex topics in a clear, succinct and engaging manner by breaking down technical terms and offering straightforward and easy to understand explanations
Author | : United States. Congress. House. Committee on the Judiciary. Subcommittee on Crime, Terrorism, and Homeland Security |
Publisher | : |
Total Pages | : 324 |
Release | : 2008 |
Genre | : Political Science |
ISBN | : |
Author | : Kimberly New |
Publisher | : Hcpro, a Division of Simplify Compliance |
Total Pages | : 0 |
Release | : 2016-11-23 |
Genre | : Medical personnel |
ISBN | : 9781556459375 |
Drug Diversion Prevention in Healthcare Kimberly New, BSN, JD Theft of controlled substances at hospitals has always been a problem of paramount importance, but even with increased security measures, it still occurs. Drug Diversion Prevention in Healthcare discusses the issue of drug diversion in detail and demonstrates the components of a solid prevention plan. Loaded with tools and checklists, this book is designed to help hospital security officials create awareness of the drug diversion problem. You will learn how to design a program to keep staff accountable for drug administrations, as well as audits that monitor drug distribution from delivery to patient administration. This resource will help you: Establish an effective drug diversion prevention plan among hospital staff Understand the fundamental issues of drug diversion Create awareness among staff using tools and checklists Learn to recognize suspected diverters and mitigate problem areas in your hospital Effectively confront and deal with diverters in your facility
Author | : Bert Spilker |
Publisher | : |
Total Pages | : 132 |
Release | : 1990 |
Genre | : Drugs |
ISBN | : |
Author | : Bert Spilker |
Publisher | : |
Total Pages | : 640 |
Release | : 1989 |
Genre | : Business & Economics |
ISBN | : |