Medicine, Science and Merck

Medicine, Science and Merck PDF Author: P. Roy Vagelos
Publisher: Cambridge University Press
ISBN: 9780521662956
Category : Biography & Autobiography
Languages : en
Pages : 326

Get Book Here

Book Description
This book traces the careers of Roy Vagelos, who eventually became the CEO of Merck and Co., Inc.

Medicine, Science and Merck

Medicine, Science and Merck PDF Author: P. Roy Vagelos
Publisher: Cambridge University Press
ISBN: 9780521662956
Category : Biography & Autobiography
Languages : en
Pages : 326

Get Book Here

Book Description
This book traces the careers of Roy Vagelos, who eventually became the CEO of Merck and Co., Inc.

Public Health Effectiveness of the FDA 510(k) Clearance Process

Public Health Effectiveness of the FDA 510(k) Clearance Process PDF Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309162904
Category : Medical
Languages : en
Pages : 141

Get Book Here

Book Description
The Food and Drug Administration (FDA) is responsible for assuring that medical devices are safe and effective before they go on the market. As part of its assessment of FDA's premarket clearance process for medical devices, the IOM held a workshop June 14-15 to discuss how to best balance patient safety and technological innovation. This document summarizes the workshop.

The Trials of Psychedelic Therapy

The Trials of Psychedelic Therapy PDF Author: Matthew Oram
Publisher: JHU Press
ISBN: 1421426218
Category : Medical
Languages : en
Pages : 413

Get Book Here

Book Description
The rise—and fall—of research into the therapeutic potential of LSD. After LSD arrived in the United States in 1949, the drug's therapeutic promise quickly captured the interests of psychiatrists. In the decade that followed, modern psychopharmacology was born and research into the drug's perceptual and psychological effects boomed. By the early 1960s, psychiatrists focused on a particularly promising treatment known as psychedelic therapy: a single, carefully guided, high-dose LSD session coupled with brief but intensive psychotherapy. Researchers reported an astounding 50 percent success rate in treating chronic alcoholism, as well as substantial improvement in patients suffering from a range of other disorders. Yet despite this success, LSD officially remained an experimental drug only. Research into its effects, psychological and otherwise, dwindled before coming to a close in the 1970s. In The Trials of Psychedelic Therapy, Matthew Oram traces the early promise and eventual demise of LSD psychotherapy in the United States. While the common perception is that LSD's prohibition terminated legitimate research, Oram draws on files from the Food and Drug Administration and the personal papers of LSD researchers to reveal that the most significant issue was not the drug's illegality, but the persistent question of its efficacy. The landmark Kefauver-Harris Drug Amendments of 1962 installed strict standards for efficacy evaluation, which LSD researchers struggled to meet due to the unorthodox nature of their treatment. Exploring the complex interactions between clinical science, regulation, and therapeutics in American medicine, The Trials of Psychedelic Therapy explains how an age of empirical research and limited government oversight gave way to sophisticated controlled clinical trials and complex federal regulations. Analyzing the debates around how to understand and evaluate treatment efficacy, this book will appeal to anyone with an interest in LSD and psychedelics, as well as mental health professionals, regulators, and scholars of the history of psychiatry, psychotherapy, drug regulation, and pharmaceutical research and development.

A Prescription for Change

A Prescription for Change PDF Author: Michael Kinch
Publisher: UNC Press Books
ISBN: 146963063X
Category : Medical
Languages : en
Pages : 355

Get Book Here

Book Description
The introduction of new medicines has dramatically improved the quantity and quality of individual and public health while contributing trillions of dollars to the global economy. In spite of these past successes--and indeed because of them--our ability to deliver new medicines may be quickly coming to an end. Moving from the beginning of the twentieth century to the present, A Prescription for Change reveals how changing business strategies combined with scientific hubris have altered the way new medicines are discovered, with dire implications for both health and the economy. To explain how we have arrived at this pivotal moment, Michael Kinch recounts the history of pharmaceutical and biotechnological advances in the twentieth century. Kinch relates stories of the individuals and organizations that built the modern infrastructure that supports the development of innovative new medicines. He shows that an accelerating cycle of acquisition and downsizing is cannibalizing that infrastructure Kinch demonstrates the dismantling of the pharmaceutical and biotechnological research and development enterprises could also provide opportunities to innovate new models that sustain and expand the introduction of newer and better breakthrough medicines in the years to come.

Generic drug entry prior to patent expiration an FTC study

Generic drug entry prior to patent expiration an FTC study PDF Author:
Publisher: DIANE Publishing
ISBN: 1428951938
Category :
Languages : en
Pages : 129

Get Book Here

Book Description


Pain Management and the Opioid Epidemic

Pain Management and the Opioid Epidemic PDF Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 0309459575
Category : Medical
Languages : en
Pages : 483

Get Book Here

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.

Rare Diseases and Orphan Products

Rare Diseases and Orphan Products PDF Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309158060
Category : Medical
Languages : en
Pages : 442

Get Book Here

Book Description
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.

The Changing Economics of Medical Technology

The Changing Economics of Medical Technology PDF Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 030904491X
Category : Medical
Languages : en
Pages : 225

Get Book Here

Book Description
Americans praise medical technology for saving lives and improving health. Yet, new technology is often cited as a key factor in skyrocketing medical costs. This volume, second in the Medical Innovation at the Crossroads series, examines how economic incentives for innovation are changing and what that means for the future of health care. Up-to-date with a wide variety of examples and case studies, this book explores how payment, patent, and regulatory policiesâ€"as well as the involvement of numerous government agenciesâ€"affect the introduction and use of new pharmaceuticals, medical devices, and surgical procedures. The volume also includes detailed comparisons of policies and patterns of technological innovation in Western Europe and Japan. This fact-filled and practical book will be of interest to economists, policymakers, health administrators, health care practitioners, and the concerned public.

Summary of the Drug Amendments of 1962

Summary of the Drug Amendments of 1962 PDF Author: United States. Food and Drug Administration
Publisher:
ISBN:
Category :
Languages : en
Pages : 12

Get Book Here

Book Description


The Regulation of Animal Drugs by the Food and Drug Administration

The Regulation of Animal Drugs by the Food and Drug Administration PDF Author: United States. Congress. House. Committee on Government Operations. Intergovernmental Relations and Human Resources Subcommittee
Publisher:
ISBN:
Category : Medicated feeds
Languages : en
Pages : 940

Get Book Here

Book Description