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Download or read book Women and Health Protection Policy Brief Transparency and the Drug Approval Process at Health Canada written by and published by . This book was released on 2007 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Ann Silversides
Publisher :
ISBN 13 :
Total Pages : 25 pages
Book Rating : 4.:/5 (246 download)
Download or read book Transparency and the Drug Approval Process at Health Canada written by Ann Silversides and published by . This book was released on 2005 with total page 25 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author :
Publisher :
ISBN 13 :
Total Pages : 0 pages
Book Rating : 4.:/5 (137 download)
Download or read book Transparency and the written by and published by . This book was released on 2005 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: The test is "marketed and promoted in ways that draw on, and perpetuate, two trends in western popular culture: (a) the medical model of the aging female body; and (b) the fear of aging and its association with disability, dependency and immobility."14 In the wake of the bone mass density testing comes the promotion of drugs that ostensibly prevent bone fractures but have little or no benefit in p [...] In 1998, during Canada-wide public consultations about replacing the Food and Drugs Act, one of the "consistent strong messages was that the lack of public confidence in Health Canada cannot be fully addressed until the activities of the department are made more transparent." Another strong message was that "the right of Canadians to be informed should prevail over the right of industry to have co [...] The prescription drug approval system Health Canada's drug approval process falls under the responsibility of the Health Products and Food Branch (HPFB), formerly known as the Health Protection Branch.27 A number of directorates and offices fall under the aegis of the HPFB. [...] The company must submit the results of all clinical trials to the regulator, regardless of their outcome.28 The information provided to Health Canada by drug companies is considered, by Health Canada, to be proprietary to the drug companies. [...] In the US, the name of a drug in the approval process is made public by the FDA on those occasions when an expert advisory committee is convened to consider the submission.
Author : R A Bouchard
Publisher : Elsevier
ISBN 13 : 1908818085
Total Pages : 298 pages
Book Rating : 4.9/5 (88 download)
Download or read book Patently Innovative written by R A Bouchard and published by Elsevier. This book was released on 2012-01-02 with total page 298 pages. Available in PDF, EPUB and Kindle. Book excerpt: Patently innovative provides a review of the importance of traditional patent law and emerging linkage regulations for pharmaceutical products on the global stage, with a focus on the linkage regime in Canada. The primary focus is on how innovation in the pharmaceutical sector can be strongly regulated and how government regulation can either stimulate or inhibit development of breakthrough products. - Includes empirical research to relate innovation to drug law - A multidisciplinary approach is taken, including the intersection of IP (intellectual property) law, drug law and innovation - Discusses the impact of government regulation on firm innovation
Author : National Academies of Sciences, Engineering, and Medicine
Publisher : National Academies Press
ISBN 13 : 0309459575
Total Pages : 483 pages
Book Rating : 4.3/5 (94 download)
Download or read book Pain Management and the Opioid Epidemic written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2017-09-28 with total page 483 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
ISBN 13 : 0309124999
Total Pages : 334 pages
Book Rating : 4.3/5 (91 download)
Download or read book Beyond the HIPAA Privacy Rule written by Institute of Medicine and published by National Academies Press. This book was released on 2009-03-24 with total page 334 pages. Available in PDF, EPUB and Kindle. Book excerpt: In the realm of health care, privacy protections are needed to preserve patients' dignity and prevent possible harms. Ten years ago, to address these concerns as well as set guidelines for ethical health research, Congress called for a set of federal standards now known as the HIPAA Privacy Rule. In its 2009 report, Beyond the HIPAA Privacy Rule: Enhancing Privacy, Improving Health Through Research, the Institute of Medicine's Committee on Health Research and the Privacy of Health Information concludes that the HIPAA Privacy Rule does not protect privacy as well as it should, and that it impedes important health research.
Author : National Academies of Sciences, Engineering, and Medicine
Publisher : National Academies Press
ISBN 13 : 0309498511
Total Pages : 103 pages
Book Rating : 4.3/5 (94 download)
Download or read book The Role of NIH in Drug Development Innovation and Its Impact on Patient Access written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2020-01-27 with total page 103 pages. Available in PDF, EPUB and Kindle. Book excerpt: To explore the role of the National Institutes of Health (NIH) in innovative drug development and its impact on patient access, the Board on Health Care Services and the Board on Health Sciences Policy of the National Academies jointly hosted a public workshop on July 24â€"25, 2019, in Washington, DC. Workshop speakers and participants discussed the ways in which federal investments in biomedical research are translated into innovative therapies and considered approaches to ensure that the public has affordable access to the resulting new drugs. This publication summarizes the presentations and discussions from the workshop.
Author : United States. Food and Drug Administration. Bureau of Drugs
Publisher :
ISBN 13 :
Total Pages : 20 pages
Book Rating : 4.3/5 (91 download)
Download or read book General Considerations for the Clinical Evaluation of Drugs written by United States. Food and Drug Administration. Bureau of Drugs and published by . This book was released on 1977 with total page 20 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : United States. Federal Trade Commission. Bureau of Consumer Protection
Publisher :
ISBN 13 :
Total Pages : 32 pages
Book Rating : 4.:/5 (31 download)
Download or read book Dietary Supplements written by United States. Federal Trade Commission. Bureau of Consumer Protection and published by . This book was released on 1998 with total page 32 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Joel Lexchin
Publisher : University of Toronto Press
ISBN 13 : 1442619619
Total Pages : 384 pages
Book Rating : 4.4/5 (426 download)
Download or read book Private Profits versus Public Policy written by Joel Lexchin and published by University of Toronto Press. This book was released on 2016-10-27 with total page 384 pages. Available in PDF, EPUB and Kindle. Book excerpt: The widespread condemnation of drastic price increases on life-saving drugs highlights our growing dependency on and vulnerability to international pharmaceutical conglomerates. However, aren’t the interests of the public supposed to supersede the pursuit of private profit? In his new work, Private Profits versus Public Policy, Joel Lexchin addresses this question as he examines how public policy with respect to the pharmaceutical industry has evolved in Canada over the past half century. Although the Canadian government is supposed to regulate the industry to serve the needs of public health, waves of deregulatory reforms and intellectual property rights legislation have shifted the balance of power in favour of these companies’ quest for profit. Joel Lexchin offers a series of recommendations to tip the scale back in the public’s favour. This enlightening work is the first book that deals exclusively with the pharmaceutical industry in Canada in over thirty years.
Author : World Intellectual Property Organization
Publisher : WIPO
ISBN 13 : 9280523082
Total Pages : 259 pages
Book Rating : 4.2/5 (85 download)
Download or read book Promoting Access to Medical Technologies and Innovation - Intersections between Public Health, Intellectual Property and Trade written by World Intellectual Property Organization and published by WIPO. This book was released on 2013 with total page 259 pages. Available in PDF, EPUB and Kindle. Book excerpt: This study has emerged from an ongoing program of trilateral cooperation between WHO, WTO and WIPO. It responds to an increasing demand, particularly in developing countries, for strengthened capacity for informed policy-making in areas of intersection between health, trade and IP, focusing on access to and innovation of medicines and other medical technologies.
Author : OECD
Publisher : OECD Publishing
ISBN 13 : 9264805907
Total Pages : 447 pages
Book Rating : 4.2/5 (648 download)
Download or read book Improving Healthcare Quality in Europe Characteristics, Effectiveness and Implementation of Different Strategies written by OECD and published by OECD Publishing. This book was released on 2019-10-17 with total page 447 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume, developed by the Observatory together with OECD, provides an overall conceptual framework for understanding and applying strategies aimed at improving quality of care. Crucially, it summarizes available evidence on different quality strategies and provides recommendations for their implementation. This book is intended to help policy-makers to understand concepts of quality and to support them to evaluate single strategies and combinations of strategies.
Author : K. Schenck-Gustafsson
Publisher : Karger Medical and Scientific Publishers
ISBN 13 : 3805599307
Total Pages : 529 pages
Book Rating : 4.8/5 (55 download)
Download or read book Handbook of Clinical Gender Medicine written by K. Schenck-Gustafsson and published by Karger Medical and Scientific Publishers. This book was released on 2012-08-17 with total page 529 pages. Available in PDF, EPUB and Kindle. Book excerpt: Gender medicine is an important new field in health and disease. It is derived from top-quality research and encompasses the biological and social determinants that underlie the susceptibility to disease and its consequences. In the future, consideration of the role of gender will undoubtedly become an integral feature of all research and clinical care. Defining the role of gender in medicine requires a broad perspective on biology and diverse skills in biomedical and social sciences. When these scientific disciplines come together, a revolution in medical care is in the making. Covering twelve different areas of medicine, the practical and useful Handbook of Clinical Gender Medicine provides up-to-date information on the role of gender in the clinical presentation, diagnosis, and management of a wide range of common diseases.
Author : The Expert Panel on the Approval and Use of Somatic Gene Therapies in Canada
Publisher : Council of Canadian Academies
ISBN 13 : 1926522796
Total Pages : 122 pages
Book Rating : 4.9/5 (265 download)
Download or read book From Research to Reality written by The Expert Panel on the Approval and Use of Somatic Gene Therapies in Canada and published by Council of Canadian Academies. This book was released on 2020-11-05 with total page 122 pages. Available in PDF, EPUB and Kindle. Book excerpt: From Research to Reality describes the stages involved in the approval and use of gene therapies in Canada, and examines challenges associated with regulatory oversight, manufacturing, access, and affordability, and identifies promising approaches to address them.
Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309132967
Total Pages : 359 pages
Book Rating : 4.3/5 (91 download)
Download or read book Crossing the Quality Chasm written by Institute of Medicine and published by National Academies Press. This book was released on 2001-07-19 with total page 359 pages. Available in PDF, EPUB and Kindle. Book excerpt: Second in a series of publications from the Institute of Medicine's Quality of Health Care in America project Today's health care providers have more research findings and more technology available to them than ever before. Yet recent reports have raised serious doubts about the quality of health care in America. Crossing the Quality Chasm makes an urgent call for fundamental change to close the quality gap. This book recommends a sweeping redesign of the American health care system and provides overarching principles for specific direction for policymakers, health care leaders, clinicians, regulators, purchasers, and others. In this comprehensive volume the committee offers: A set of performance expectations for the 21st century health care system. A set of 10 new rules to guide patient-clinician relationships. A suggested organizing framework to better align the incentives inherent in payment and accountability with improvements in quality. Key steps to promote evidence-based practice and strengthen clinical information systems. Analyzing health care organizations as complex systems, Crossing the Quality Chasm also documents the causes of the quality gap, identifies current practices that impede quality care, and explores how systems approaches can be used to implement change.
Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309164257
Total Pages : 267 pages
Book Rating : 4.3/5 (91 download)
Download or read book Finding What Works in Health Care written by Institute of Medicine and published by National Academies Press. This book was released on 2011-07-20 with total page 267 pages. Available in PDF, EPUB and Kindle. Book excerpt: Healthcare decision makers in search of reliable information that compares health interventions increasingly turn to systematic reviews for the best summary of the evidence. Systematic reviews identify, select, assess, and synthesize the findings of similar but separate studies, and can help clarify what is known and not known about the potential benefits and harms of drugs, devices, and other healthcare services. Systematic reviews can be helpful for clinicians who want to integrate research findings into their daily practices, for patients to make well-informed choices about their own care, for professional medical societies and other organizations that develop clinical practice guidelines. Too often systematic reviews are of uncertain or poor quality. There are no universally accepted standards for developing systematic reviews leading to variability in how conflicts of interest and biases are handled, how evidence is appraised, and the overall scientific rigor of the process. In Finding What Works in Health Care the Institute of Medicine (IOM) recommends 21 standards for developing high-quality systematic reviews of comparative effectiveness research. The standards address the entire systematic review process from the initial steps of formulating the topic and building the review team to producing a detailed final report that synthesizes what the evidence shows and where knowledge gaps remain. Finding What Works in Health Care also proposes a framework for improving the quality of the science underpinning systematic reviews. This book will serve as a vital resource for both sponsors and producers of systematic reviews of comparative effectiveness research.
Author : Gregory P. Marchildon
Publisher : University of Toronto Press
ISBN 13 : 1487508085
Total Pages : 235 pages
Book Rating : 4.4/5 (875 download)
Download or read book Health Systems in Transition Third Edition written by Gregory P. Marchildon and published by University of Toronto Press. This book was released on 2021-04-21 with total page 235 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides insight into how the Canadian health care system is financed and organized, how it has evolved over time, and how well it performs relative to peer countries.
