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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.
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 : Joel Lexchin
Publisher : Canadian Centre Policy Alternatives
ISBN 13 : 0886273854
Total Pages : 32 pages
Book Rating : 4.8/5 (862 download)
Download or read book Transparency in Drug Regulation written by Joel Lexchin and published by Canadian Centre Policy Alternatives. This book was released on 2004 with total page 32 pages. Available in PDF, EPUB and Kindle. Book excerpt: One way this relationship is manifested is the But the state does not possess the wherewithal to agreement between the industry and the TPD that undertake the elaborate clinical and pre-clinical all of the information that companies submit as trials required to meet the objective of providing part of the regulatory approval process is deemed safe and effective medications. [...] Accordingly, in November 1996 I made a "loaned" to the government for purposes of review request through the Access to Information Act for but the companies do so with the expectation that "all studies that the Health Protection Branch has the review will produce material gains through that deal with the question of the efficacy of: marketing of their products. [...] Personal data or usefulness of the data submitted; the scientific that enters the files of regulatory agencies like the atmosphere in the agency may be stifled and the TPD can include the identity of individual patients professional growth of its staff severely inhibited. [...] This part of the Out of the three proposals that have been put protocol was not followed and the authors made forward, the use of SBDs is the most advanced conclusions about subgroups despite the lack of and therefore merits a detailed analysis. [...] Canadian Centre for Policy Alternatives VII: Is the Summary Basis of Decision Adequate IN EACH OF THE FOUR EXAMPLES the Once a drug has been approved in the United problems would not have been discovered using States the FDA posts on its web site a detailed sum- Health Canada's SBDs due to the lack of detailed mary of the information that the company has sub- information of various types in these.
Author : Katherine Fierlbeck
Publisher : University of Toronto Press
ISBN 13 : 148752904X
Total Pages : 303 pages
Book Rating : 4.4/5 (875 download)
Download or read book Transparency, Power, and Influence in the Pharmaceutical Industry written by Katherine Fierlbeck and published by University of Toronto Press. This book was released on 2021 with total page 303 pages. Available in PDF, EPUB and Kindle. Book excerpt: Transparency, Power, and Influence in the Pharmaceutical Industry evaluates the progress made in holding the pharmaceutical industry to account through greater transparency.
Author : Michael McBane
Publisher : Canadian Centre Policy Alternatives
ISBN 13 : 0886274052
Total Pages : 138 pages
Book Rating : 4.8/5 (862 download)
Download or read book Ill-health Canada written by Michael McBane and published by Canadian Centre Policy Alternatives. This book was released on 2005 with total page 138 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309316324
Total Pages : 236 pages
Book Rating : 4.3/5 (93 download)
Download or read book Sharing Clinical Trial Data written by Institute of Medicine and published by National Academies Press. This book was released on 2015-04-20 with total page 236 pages. Available in PDF, EPUB and Kindle. Book excerpt: Data sharing can accelerate new discoveries by avoiding duplicative trials, stimulating new ideas for research, and enabling the maximal scientific knowledge and benefits to be gained from the efforts of clinical trial participants and investigators. At the same time, sharing clinical trial data presents risks, burdens, and challenges. These include the need to protect the privacy and honor the consent of clinical trial participants; safeguard the legitimate economic interests of sponsors; and guard against invalid secondary analyses, which could undermine trust in clinical trials or otherwise harm public health. Sharing Clinical Trial Data presents activities and strategies for the responsible sharing of clinical trial data. With the goal of increasing scientific knowledge to lead to better therapies for patients, this book identifies guiding principles and makes recommendations to maximize the benefits and minimize risks. This report offers guidance on the types of clinical trial data available at different points in the process, the points in the process at which each type of data should be shared, methods for sharing data, what groups should have access to data, and future knowledge and infrastructure needs. Responsible sharing of clinical trial data will allow other investigators to replicate published findings and carry out additional analyses, strengthen the evidence base for regulatory and clinical decisions, and increase the scientific knowledge gained from investments by the funders of clinical trials. The recommendations of Sharing Clinical Trial Data will be useful both now and well into the future as improved sharing of data leads to a stronger evidence base for treatment. This book will be of interest to stakeholders across the spectrum of research-from funders, to researchers, to journals, to physicians, and ultimately, to patients.
Author : National Academies of Sciences, Engineering, and Medicine
Publisher : National Academies Press
ISBN 13 : 0309498635
Total Pages : 169 pages
Book Rating : 4.3/5 (94 download)
Download or read book Regulating Medicines in a Globalized World written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2020-04-25 with total page 169 pages. Available in PDF, EPUB and Kindle. Book excerpt: Globalization is rapidly changing lives and industries around the world. Drug development, authorization, and regulatory supervision have become international endeavors, with most medicines becoming global commodities. Drug companies utilize global supply chains that often include facilities in countries with inconsistent regulations from those of the United States, perform pivotal trials in multiple countries to support registration submissions in various jurisdictions, and subsequently market their medicines throughout most of the world. These companies operate across borders and require individual national regulators to ensure that drugs authorized for use in their countries are safe and effective, and appropriate for their health care system and their population. This process involves significant resources and often duplicative work. It is important to consider how this process can be improved in order to better allocate resources, time, and efforts to improve public health. Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators considers the role of mutual recognition and other reliance activities among regulators in contributing to enhancing public health. This report identifies opportunities for leveraging reliance activities more broadly in order to potentially impact public health globally. Key topics in this report include the job of medicines regulators in today's world, what policy makers need to know about today's regulatory environment, stakeholder views of recognition and reliance, as well as removing impediments and facilitating action for greater recognition and reliance among regulatory authorities.
Author : Colleen M. Flood
Publisher : University of Ottawa Press
ISBN 13 : 077663643X
Total Pages : 850 pages
Book Rating : 4.7/5 (766 download)
Download or read book Vulnerable written by Colleen M. Flood and published by University of Ottawa Press. This book was released on 2020-07-14 with total page 850 pages. Available in PDF, EPUB and Kindle. Book excerpt: The novel coronavirus SARS-CoV-2, which causes the disease known as COVID-19, has infected people in 212 countries so far and on every continent except Antarctica. Vast changes to our home lives, social interactions, government functioning and relations between countries have swept the world in a few months and are difficult to hold in one’s mind at one time. That is why a collaborative effort such as this edited, multidisciplinary collection is needed. This book confronts the vulnerabilities and interconnectedness made visible by the pandemic and its consequences, along with the legal, ethical and policy responses. These include vulnerabilities for people who have been harmed or will be harmed by the virus directly and those harmed by measures taken to slow its relentless march; vulnerabilities exposed in our institutions, governance and legal structures; and vulnerabilities in other countries and at the global level where persistent injustices harm us all. Hopefully, COVID-19 will forces us to deeply reflect on how we govern and our policy priorities; to focus preparedness, precaution, and recovery to include all, not just some. Published in English with some chapters in French.
Author : National Academies of Sciences, Engineering, and Medicine
Publisher : National Academies Press
ISBN 13 : 0309468086
Total Pages : 235 pages
Book Rating : 4.3/5 (94 download)
Download or read book Making Medicines Affordable written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2018-03-01 with total page 235 pages. Available in PDF, EPUB and Kindle. Book excerpt: Thanks to remarkable advances in modern health care attributable to science, engineering, and medicine, it is now possible to cure or manage illnesses that were long deemed untreatable. At the same time, however, the United States is facing the vexing challenge of a seemingly uncontrolled rise in the cost of health care. Total medical expenditures are rapidly approaching 20 percent of the gross domestic product and are crowding out other priorities of national importance. The use of increasingly expensive prescription drugs is a significant part of this problem, making the cost of biopharmaceuticals a serious national concern with broad political implications. Especially with the highly visible and very large price increases for prescription drugs that have occurred in recent years, finding a way to make prescription medicinesâ€"and health care at largeâ€"more affordable for everyone has become a socioeconomic imperative. Affordability is a complex function of factors, including not just the prices of the drugs themselves, but also the details of an individual's insurance coverage and the number of medical conditions that an individual or family confronts. Therefore, any solution to the affordability issue will require considering all of these factors together. The current high and increasing costs of prescription drugsâ€"coupled with the broader trends in overall health care costsâ€"is unsustainable to society as a whole. Making Medicines Affordable examines patient access to affordable and effective therapies, with emphasis on drug pricing, inflation in the cost of drugs, and insurance design. This report explores structural and policy factors influencing drug pricing, drug access programs, the emerging role of comparative effectiveness assessments in payment policies, changing finances of medical practice with regard to drug costs and reimbursement, and measures to prevent drug shortages and foster continued innovation in drug development. It makes recommendations for policy actions that could address drug price trends, improve patient access to affordable and effective treatments, and encourage innovations that address significant needs in health care.
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 : Katherine Fierlbeck
Publisher : University of Toronto Press
ISBN 13 : 1487529066
Total Pages : 303 pages
Book Rating : 4.4/5 (875 download)
Download or read book Transparency, Power, and Influence in the Pharmaceutical Industry written by Katherine Fierlbeck and published by University of Toronto Press. This book was released on 2021-06-29 with total page 303 pages. Available in PDF, EPUB and Kindle. Book excerpt: There is plenty of controversy surrounding pharmaceuticals, but it cannot be denied that the pharmaceutical industry is both socially beneficial and profitable. Regulators are expected to ensure that the economic success of the industry does not come at the expense of public safety, yet they have also assumed a cooperative role by providing advice on regulation and by targeting unmet medical needs. Concerns over regulatory standards, conflicts of interest, and the manipulation of information on drug safety and effectiveness have led to public mistrust and a greater need for transparency between the pharmaceutical industry and government regulators. Transparency, Power, and Influence in the Pharmaceutical Industry evaluates the progress made in holding the pharmaceutical industry responsible for creating transparency in the industry, from development to market. The contributors to this volume examine the various mechanisms introduced to make the regulatory process more informative and situate these efforts within the larger project of enhancing the safety of drugs, vaccines, and other products.
Author : David Pryde
Publisher : Royal Society of Chemistry
ISBN 13 : 1782624201
Total Pages : 487 pages
Book Rating : 4.7/5 (826 download)
Download or read book Orphan Drugs and Rare Diseases written by David Pryde and published by Royal Society of Chemistry. This book was released on 2014-07-30 with total page 487 pages. Available in PDF, EPUB and Kindle. Book excerpt: Orphan drugs are designated drug substances that are intended to treat rare or ‘orphan’ diseases. More than 7000 rare diseases are known that collectively affect some 6-7% of the developed world’s population; however, individually, any single, rare disease may only affect a handful of people making them commercially unattractive for the biopharmaceutical industry to target. Ground breaking legislation, starting with the Orphan Drug Act that was passed in the US in 1983 to provide financial incentives for companies to develop orphan drugs, has sparked ever increasing interest from biopharmaceutical companies to tackle rare diseases. These developments have made rare diseases, and the orphan drugs that treat them, sufficiently attractive to pharmaceutical development and many pharmaceutical companies now have research units dedicated to this area of research. It is therefore timely to review the area of orphan drugs and some of the basic science, drug discovery and regulatory factors that underpin this important, and growing, area of biomedical research. Written by a combination of academic and industry experts working in the field, this text brings together expert authors in the regulatory, drug development, genetics, biochemistry, patient advocacy group, medicinal chemistry and commercial domains to create a unique and timely reference for all biomedical researchers interested in finding out more about orphan drugs and the rare diseases they treat. Providing an up-to-date monograph, this book covers the basic science, drug discovery and regulatory elements behind orphan drugs and will appeal to medicinal and pharmaceutical chemists, biochemists and anyone working within the fields of rare disease research and drug development or pharmaceuticals in industry or academia.
Author : Peter Crawford Oliver
Publisher : Oxford University Press
ISBN 13 : 0190664819
Total Pages : 1169 pages
Book Rating : 4.1/5 (96 download)
Download or read book The Oxford Handbook of the Canadian Constitution written by Peter Crawford Oliver and published by Oxford University Press. This book was released on 2017 with total page 1169 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Oxford Handbook of the Canadian Constitution provides an ideal first stop for Canadians and non-Canadians seeking a clear, concise, and authoritative account of Canadian constitutional law. The Handbook is divided into six parts: Constitutional History, Institutions and Constitutional Change, Aboriginal Peoples and the Canadian Constitution, Federalism, Rights and Freedoms, and Constitutional Theory. Readers of this Handbook will discover some of the distinctive features of the Canadian constitution: for example, the importance of Indigenous peoples and legal systems, the long-standing presence of a French-speaking population, French civil law and Quebec, the British constitutional heritage, the choice of federalism, as well as the newer features, most notably the Canadian Charter of Rights and Freedoms, Section Thirty-Five regarding Aboriginal rights and treaties, and the procedures for constitutional amendment. The Handbook provides a remarkable resource for comparativists at a time when the Canadian constitution is a frequent topic of constitutional commentary. The Handbook offers a vital account of constitutional challenges and opportunities at the time of the 150th anniversary of Confederation.
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 : Kıymet Tunca Çalıyurt
Publisher : Springer Nature
ISBN 13 : 9811514240
Total Pages : 266 pages
Book Rating : 4.8/5 (115 download)
Download or read book Integrity, Transparency and Corruption in Healthcare & Research on Health, Volume I written by Kıymet Tunca Çalıyurt and published by Springer Nature. This book was released on 2020-02-03 with total page 266 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book grapples with the numerous risks organizations face in order to succeed. These include economic risks, disaster risks, supply-chain risks, regulatory risks, and technology risks, all of which affect organizations in different ways and in varying degrees. Referencing Mahatma Gandhi’s seven unethical behaviors in the business world—wealth without work, pleasure without conscience, knowledge without character, commerce without morality, science without humanity, religion without sacrifice, and politics without principle—the authors analyze the healthcare sector. As competition in the health sector increases, there has also been a rise in unethical behavior. Corruption in the health sector results in severe consequences as it could affect the health of millions. This volume explores fraud schemes and cases, legislation to avoid cheating, lack of law, transparency, ethical issues, corporate governance and transparency in the health and pharmaceutical sector bringing together the perspectives of practitioners, professionals, as well as academic authors.
Author : Rick Ng
Publisher : John Wiley & Sons
ISBN 13 : 1118210700
Total Pages : 368 pages
Book Rating : 4.1/5 (182 download)
Download or read book Drugs written by Rick Ng and published by John Wiley & Sons. This book was released on 2011-09-20 with total page 368 pages. Available in PDF, EPUB and Kindle. Book excerpt: "Concise and easy to read, the book quickly introduces basic concepts, then moves on to discuss target selection and the drug discovery process for both small and large molecular drugs." —Doody's Reviews, May 2009 "The second edition of a book that offers a user-friendly step-by-step introduction to all the key processes involved in bringing a drug to the market, including the performance of preclinical trials." —Chemistry World, February 2009 The new edition of this best-selling book continues to offer a user-friendly, step-by-step introduction to all the key processes involved in bringing a drug to the market, including the performance of pre-clinical studies, the conduct of human clinical trials, regulatory controls, and even the manufacturing processes for pharmaceutical products. Concise and easy to read, the book quickly introduces basic concepts, then moves on to discuss target selection and the drug discovery process for both small and large molecular drugs. This second edition features many key enhancements, including Key Points, Chapter Summary, and Review Questions in each chapter, Answers to Review Questions provided in a book-end appendix, and one or two carefully selected "mini" case studies in each chapter. Richly illustrated throughout with over ninety figures and tables, this important book also includes helpful listings of current FDA and European guidelines and a special section on regulatory authority and processes in China. It is an indispensable resource for pharmaceutical industry and academic researchers, pharmaceutical managers and executives, healthcare clinicians, policymakers, regulators, and lobbyists with an interest in drug development. It is also an excellent textbook for students in pharmacy, science, and medicine courses.
