The Law of Emergencies

The Law of Emergencies
Author: Nan D. Hunter
Publisher: Butterworth-Heinemann
Total Pages: 435
Release: 2017-08-08
Genre: Law
ISBN: 0128043229
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The Law of Emergencies: Public Health and Disaster Management, Second Edition, introduces the American legal system as it interacts with disaster management, public health and civil unrest issues. Nan Hunter shows how the law in this area plays out in the context of real life emergencies where individuals often have to make split-second decisions. This book covers the major legal principles underlying emergency policy and operations and analyzes legal authority at the federal, state and local levels, placing the issues in historical context but concentrating on contemporary questions. The book includes primary texts, reader-friendly expository explanation and sample discussion questions in each chapter, as well as scenarios for each of the three major areas to put the concepts in to action. Prior knowledge of the law is not necessary in order to use and understand this book, and it satisfies the need of professionals in a wide array of fields related to emergency management to understand both what the law requires and how to analyze issues for which there is no clear legal answer. The book features materials on such critical issues as how to judge the extent of Constitutional authority for government to intervene in the lives and property of American citizens. At the same time, it also captures bread-and-butter issues such as responder liability and disaster relief methods. No other book brings these components together in a logically organized, step by step fashion. - Updated with expanded coverage and several new chapters - Re-organized to improve topic focus, with sections covering The President, Congress, and the Courts; Governance on the Ground; The Rights of Individuals; Disaster Management and Reconstruction; Health Emergencies; Preserving the Social Fabric; and Liability - Includes a new disaster scenario (a dirty bomb explosion in Washington, DC) to illustrate the application of key concepts - Features two new appendices that provide key excerpts from the U.S. Constitution and the Stafford Act - Includes a new glossary of legal and legislative terms

Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated (Us Food and Drug Administration Regulation) (Fda) (2018 Edition)

Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated (Us Food and Drug Administration Regulation) (Fda) (2018 Edition)
Author: The Law The Law Library
Publisher: Createspace Independent Publishing Platform
Total Pages: 120
Release: 2018-09-22
Genre:
ISBN: 9781727546538
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Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated (US Food and Drug Administration Regulation) (FDA) (2018 Edition) The Law Library presents the complete text of the Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated (US Food and Drug Administration Regulation) (FDA) (2018 Edition). Updated as of May 29, 2018 The Food and Drug Administration (FDA) is amending its regulations governing drug establishment registration and drug listing. These amendments reorganize, modify, and clarify current regulations concerning who must register establishments and list human drugs, human drugs that are also biological products, and animal drugs. The final rule requires electronic submission, unless waived in certain circumstances, of registration and listing information. This rulemaking pertains to finished drug products and to active pharmaceutical ingredients (APIs) alone or together with one or more other ingredients. The final rule describes how and when owners or operators of establishments at which drugs are manufactured or processed must register their establishments with FDA and list the drugs they manufacture or process. In addition, the rule makes certain changes to the National Drug Code (NDC) system. We are taking this action to improve management of drug establishment registration and drug listing requirements and make these processes more efficient and effective for industry and for us. This action also supports implementation of the electronic prescribing provisions of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) and the availability of current drug labeling information through DailyMed, a computerized repository of drug information maintained by the National Library of Medicine. This book contains: - The complete text of the Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated (US Food and Drug Administration Regulation) (FDA) (2018 Edition) - A table of contents with the page number of each section

Complementary and Alternative Medicine in the United States

Complementary and Alternative Medicine in the United States
Author: Institute of Medicine
Publisher: National Academies Press
Total Pages: 360
Release: 2005-04-13
Genre: Medical
ISBN: 0309133424
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Integration of complementary and alternative medicine therapies (CAM) with conventional medicine is occurring in hospitals and physicians offices, health maintenance organizations (HMOs) are covering CAM therapies, insurance coverage for CAM is increasing, and integrative medicine centers and clinics are being established, many with close ties to medical schools and teaching hospitals. In determining what care to provide, the goal should be comprehensive care that uses the best scientific evidence available regarding benefits and harm, encourages a focus on healing, recognizes the importance of compassion and caring, emphasizes the centrality of relationship-based care, encourages patients to share in decision making about therapeutic options, and promotes choices in care that can include complementary therapies where appropriate. Numerous approaches to delivering integrative medicine have evolved. Complementary and Alternative Medicine in the United States identifies an urgent need for health systems research that focuses on identifying the elements of these models, the outcomes of care delivered in these models, and whether these models are cost-effective when compared to conventional practice settings. It outlines areas of research in convention and CAM therapies, ways of integrating these therapies, development of curriculum that provides further education to health professionals, and an amendment of the Dietary Supplement Health and Education Act to improve quality, accurate labeling, research into use of supplements, incentives for privately funded research into their efficacy, and consumer protection against all potential hazards.

Mastering and Managing the FDA Maze

Mastering and Managing the FDA Maze
Author: Gordon Harnack
Publisher: Quality Press
Total Pages: 501
Release: 2014-07-18
Genre: Business & Economics
ISBN: 1636940463
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The number of FDA regulations and the agency’s increased expectations is staggering and their content tedious, creating a regulated industry need for compliance insight and appropriate detail. This book is the reference needed to successfully navigate through the FDA maze! The target audiences for this desk reference include: Regulatory professionals, who know their responsibility to keep their firm’s employees trained and competent on FDA device regulations and who need a preliminary desk reference that can be used throughout their enterprise to help train and ensure compliance Neophytes, who know nothing about FDA but need a resource that provides both broad and specific information in sufficient detail to be useful Beginners, who know a little about FDA, need to know more, and need a reference tool to help them be more effective and productive on the job Intermediates, who knows enough about FDA to know they need to know more and who need a reference tool that provides them with both more basics and executable detail Busy managers, who need to know regulatory requirements and FDA expectations in order to manage compliance in their specific activity Busy executives (CEOs, COOs, and operations managers, whom FDA holds responsible for all regulatory compliance), who also need a desk reference with specific information to quickly assess regulatory compliance, identify potential noncompliance, and review corrective, preventive, and compliance actions