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Author: Peter Temin
Publisher:
ISBN:
Category : Business & Economics
Languages : en
Pages : 296
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Book Description
A history of the federal regulation of the sale and use of medicinal drugs throughout the twentieth century examines the reasons for and impact of Federal Food and Drug Administration.
![The History of Drug Regulation [in the United States]. PDF](https://books.google.com/books/content/images/frontcover/TFACoQEACAAJ?fife=w80-h100)
Author: United States. Food and Drug Administration
Publisher:
ISBN:
Category : Drug approval
Languages : en
Pages : 12
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Book Description
Author: Peter Temin
Publisher:
ISBN:
Category : Business & Economics
Languages : en
Pages : 296
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Book Description
A history of the federal regulation of the sale and use of medicinal drugs throughout the twentieth century examines the reasons for and impact of Federal Food and Drug Administration.
Author: Committee on Federal Regulation of Methadone Treatment
Publisher: National Academies Press
ISBN: 0309598621
Category : Medical
Languages : en
Pages : 251
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Book Description
For nearly three decades, methadone hydrochloride has been the primary means of treating opiate addiction. Today, about 115,000 people receive such treatment, and thousands more have benefited from it in the past. Even though methadone's effectiveness has been well established, its use remains controversial, a fact reflected by the extensive regulation of its manufacturing, labeling, distribution, and use. The Food and Drug Administration regulates the safety and effectiveness of methadone, as it does for all drugs, and the Drug Enforcement Administration regulates it as a controlled substance. However, methadone is also subjected to a unique additional tier of regulation that prescribes how and under what circumstances it may be used to treat opiate addiction. Federal Regulation of Methadone Treatment examines current Department of Health and Human Services standards for narcotic addiction treatment and the regulation of methadone treatment programs pursuant to those standards. The book includes an evaluation of the effect of federal regulations on the provision of methadone treatment services and an exploration of options for modifying the regulations to allow optimal clinical practice. The volume also includes an assessment of alternatives to the existing regulations.
Author: Kathleen L. Wessels-Cruz
Publisher:
ISBN:
Category : Clinical trials
Languages : en
Pages : 462
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Book Description
Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 0309459575
Category : Medical
Languages : en
Pages : 483
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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: Stephen M. Kanovsky
Publisher:
ISBN: 9781935065876
Category : Drugs
Languages : en
Pages : 672
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Book Description
FDLI's popular reference book, A Practical Guide to FDA's Food and Drug Law and Regulation, Seventh Edition, provides an introduction to the laws and regulations governing development, marketing, and sale of FDA-regulated products, including topics on food, drugs, medical devices, biologics, dietary supplements, cosmetics, new animal drugs, cannabis, and tobacco and nicotine products. Structured to serve as a reference and as a teaching tool, the book offers practical legal and regulatory fundamentals, and each chapter builds sequentially from the last to provide an accessible overview of the key topics relevant to practitioners of food and drug law and regulation. This book is a standard legal text in law schools and graduate regulatory programs and has been cited as a reference in judicial opinions (including the U.S. Supreme Court). This Seventh Edition includes new sections on controlled substances, compounded drugs, and cannabis and cannabis-derived compounds. It also incorporates the latest amendments to the Federal Food, Drug, and Cosmetic Act, as well as FDA regulations and guidances.
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309048370
Category : Medical
Languages : en
Pages : 239
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Book Description
Like many other agencies of the federal government, the Food and Drug Administration (FDA) relies extensively on external advisory committees for independent scientific and technical advice. Recognizing that the existing advisory committee system is essentially sound, this volume recommends ways of enhancing the use of these committees in the evaluation of drugs, biological materials, and medical devices; strengthening the agency's management of the system; and increasing the accountability of the system to the public. In doing so, it examines and makes recommendations on such issues as the recruitment of committee members, the FDA's management of financial conflict of interest and intellectual bias among members, and the operations and management of the advisory committee system.
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309212456
Category : Medical
Languages : en
Pages : 318
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Book Description
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: National Research Council
Publisher: National Academies Press
ISBN: 0309046289
Category : Medical
Languages : en
Pages : 337
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Book Description
Europe's "Black Death" contributed to the rise of nation states, mercantile economies, and even the Reformation. Will the AIDS epidemic have similar dramatic effects on the social and political landscape of the twenty-first century? This readable volume looks at the impact of AIDS since its emergence and suggests its effects in the next decade, when a million or more Americans will likely die of the disease. The Social Impact of AIDS in the United States addresses some of the most sensitive and controversial issues in the public debate over AIDS. This landmark book explores how AIDS has affected fundamental policies and practices in our major institutions, examining: How America's major religious organizations have dealt with sometimes conflicting values: the imperative of care for the sick versus traditional views of homosexuality and drug use. Hotly debated public health measures, such as HIV antibody testing and screening, tracing of sexual contacts, and quarantine. The potential risk of HIV infection to and from health care workers. How AIDS activists have brought about major change in the way new drugs are brought to the marketplace. The impact of AIDS on community-based organizations, from volunteers caring for individuals to the highly political ACT-UP organization. Coping with HIV infection in prisons. Two case studies shed light on HIV and the family relationship. One reports on some efforts to gain legal recognition for nonmarital relationships, and the other examines foster care programs for newborns with the HIV virus. A case study of New York City details how selected institutions interact to give what may be a picture of AIDS in the future. This clear and comprehensive presentation will be of interest to anyone concerned about AIDS and its impact on the country: health professionals, sociologists, psychologists, advocates for at-risk populations, and interested individuals.
Author: Jonathon Erlen
Publisher: CRC Press
ISBN: 9780789018922
Category : Medical
Languages : en
Pages : 258
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Book Description
A comprehensive look at the beginnings of the current drug problems in the United States Federal Drug Control: The Evolution of Policy and Practice presents an overview of the key issues and key individuals responsible for the creation of the federal government’s efforts to control illegal drugs in the United States, from 1875-2001. The book focuses special attention on federal legislation that constructed the federal drug regulatory machinery and the Supreme Court cases that interpreted these laws and their implementation. An esteemed panel of scholars, including co-editor Joseph Spillane, author of Cocaine: From Medical Marvel to Modern Menace, and William B. McAllister, author of Drug Diplomacy in the Twentieth Century: An International History, traces the internal tensions between factions favoring medicalization and criminalization throughout the 20th century, examining the difficult choices that continue to be made in this ongoing debate. The central question in the government’s response to the crisis of illicit drugs in the United States has remained the same for more than 125 years: Should the government rely on educational and treatment programs or turn to the criminal justice system for answers? Federal Drug Control examines the historic turning points of the debate, including the 19th Century origins of the controversy, legislation and subsequent Supreme Court decisions in the 20th Century, international attempts at drug control agreements, and the emergence of new illicit drugs. The book also looks at the influential figures of the debate, including Levi Nutt, Lawrence Kolb, Richard Pearson Hobson, A.G. DuMez, and Harry J. Anslinger who ran the Federal Bureau of Narcotics (FBN) for more than 30 years. Federal Drug Control examines: the history of cocaine use in the 20th Century the history of marijuana use in the 20th Century the advent of psychotropic drugs in the 1960s the origins of the Harrison Narcotic Act the federal government’s efforts to limit the pharmacy profession’s control over prescription drugs and much more! Federal Drug Control: The Evolution of Policy and Practice is an essential resource for criminologists, historians, social historians, sociologists, anthropologists, public policymakers, academics, and anyone interested in the broad issues involved in how the federal government deals with the problem of illicit drugs in the United States.
