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Transparency In Drug Regulation
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Book Synopsis Transparency in Drug Regulation by : Joel Lexchin
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.
Book Synopsis Transparency, Power, and Influence in the Pharmaceutical Industry by : Katherine Fierlbeck
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.
Book Synopsis Sharing Clinical Trial Data by : Institute of Medicine
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 :0309468086 Total Pages :235 pages Book Rating :4.3/5 (94 download)
Book Synopsis Making Medicines Affordable by : National Academies of Sciences, Engineering, and Medicine
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.
Book Synopsis Effective Drug Regulation by : Ratanawijitrasin S
Download or read book Effective Drug Regulation written by Ratanawijitrasin S and published by World Health Organization. This book was released on 2002-06 with total page 202 pages. Available in PDF, EPUB and Kindle. Book excerpt: Seven independent variables were used including the five financing instruments, the firm's ordinary debt, and the firm's operating risk.
Author :United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health Publisher : ISBN 13 : Total Pages :224 pages Book Rating :4.F/5 ( download)
Book Synopsis Improving Predictability and Transparency in DEA and FDA Regulation by : United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health
Download or read book Improving Predictability and Transparency in DEA and FDA Regulation written by United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health and published by . This book was released on 2015 with total page 224 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Transparency in Health and Health Care in the United States by : Holly Fernandez Lynch
Download or read book Transparency in Health and Health Care in the United States written by Holly Fernandez Lynch and published by Cambridge University Press. This book was released on 2019-06-06 with total page 373 pages. Available in PDF, EPUB and Kindle. Book excerpt: Examines the impact of increased transparency on the legal, medical, and business structures of the American health care system.
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)
Book Synopsis Regulating Medicines in a Globalized World by : National Academies of Sciences, Engineering, and Medicine
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.
Book Synopsis Improving Regulatory Transparency for New Medical Therapies Act by : United States. Congress. House. Committee on Energy and Commerce
Download or read book Improving Regulatory Transparency for New Medical Therapies Act written by United States. Congress. House. Committee on Energy and Commerce and published by . This book was released on 2015 with total page 136 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Clinical Trial Transparency in the Americas by : Trudo Lemmens
Download or read book Clinical Trial Transparency in the Americas written by Trudo Lemmens and published by . This book was released on 2018 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Notwithstanding widespread support for clinical trials data transparency, its implementation faces significant challenges. Transparency of pharmaceutical data has been hampered by some industry resistance, by the qualification of such data as commercially confidential information, and by inconsistencies in overlapping regulatory spheres. This article discusses key developments related to registering pharmaceutical clinical trials and sharing data submitted to drug regulatory agencies in the Americas. Then, reports from three countries (Argentina, Brazil, Canada) are discussed to show what transparency measures they have implemented and what challenges remain. These short case studies shed light on various initiatives, positive outcomes, and persistent challenges -- even in countries with relatively advanced research, pharmaceutical product production, and regulatory sectors. They further highlight how different jurisdictions address the tension between public-health-oriented transparency initiatives and the tendency to treat data as commercial goods. Finally, the paper suggests that research ethics review could play a role in moving forward with data transparency, but it puts forward that research ethics governance ought to be developed more coherently in order to ensure the public accountability of the governance system.
Book Synopsis Rare Diseases and Orphan Products by : Institute of Medicine
Download or read book Rare Diseases and Orphan Products written by Institute of Medicine and published by National Academies Press. This book was released on 2011-04-03 with total page 442 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Improving Regulatory Transparency for New Medical Therapies Act by : United States. Congress. House. Committee on Energy and Commerce
Download or read book Improving Regulatory Transparency for New Medical Therapies Act written by United States. Congress. House. Committee on Energy and Commerce and published by . This book was released on 2014 with total page 12 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis International Drug Regulatory Mechanisms by : Albert I. Wertheimer
Download or read book International Drug Regulatory Mechanisms written by Albert I. Wertheimer and published by CRC Press. This book was released on 2022-02-15 with total page 382 pages. Available in PDF, EPUB and Kindle. Book excerpt: Learn how international governments have committed themselves to improving access to quality health care! International Drug Regulatory Mechanisms explores the environment, organization, structure, functioning, and finance of health systems and pharmaceutical markets in 19 countries. Local experts describe each country’s experiences with and lessons learned from the regulation of pharmaceutical products. This book will help government officials, pharmacy educators, and pharmaceutical industry leaders from around the globe identify and develop successful methods for controlling pharmaceutical drug prices and utilization. In International Drug Regulatory Mechanisms, you will learn about the health care system of each country and each government’s measures to control drug costs. This text shows you what government interventions are feasible as well as effective, and the impact of these measures on consumers, government agencies, and the pharmaceutical companies and distributors. Drug policies, reimbursement concepts, and health insurance companies are all examined to give you a better working knowledge of the methodology and guidelines involving drug control in nations such as: Iceland Canada Israel Malaysia Argentina Taiwan Mexico Italy International Drug Regulatory Mechanisms is an extensive text that shows how pharmaceuticals are regulated throughout the world. This book examines how—despite similar goals—price controls, utilization controls, record keeping, and quality requirements differ greatly between countries. Using numerous graphs, tables, and figures, this one-of-a-kind resouce provides you with new insight into which strategies are superior and how to implement these strategies in your own country.
Author :Who Regional Office for the Eastern Medi Publisher :World Health Organization ISBN 13 :9290216492 Total Pages :71 pages Book Rating :4.2/5 (92 download)
Book Synopsis Measuring Transparency to Improve Good Governance in the Public Pharmaceutical Sector by : Who Regional Office for the Eastern Medi
Download or read book Measuring Transparency to Improve Good Governance in the Public Pharmaceutical Sector written by Who Regional Office for the Eastern Medi and published by World Health Organization. This book was released on 2009 with total page 71 pages. Available in PDF, EPUB and Kindle. Book excerpt: This report presents the findings of the first phase of the national Good Governance for Medicines programme in Jordan. In recent years, countries of the WHO Eastern Mediterranean Region have made significant achievements in the provision of health services. In the pharmaceutical field, countries have been striving to improve the structures and regulations pertaining to medicines and have progressed in many ways. However, there are still important challenges. The goal of the WHO Good Governance for Medicines programme is to improve the situation of medicines regulation and supply. National transparency assessment is the beginning of a process aimed at bringing about desirable and sustainable changes in the governance of the pharmaceutical sector.
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)
Book Synopsis Pain Management and the Opioid Epidemic by : National Academies of Sciences, Engineering, and Medicine
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.
Book Synopsis Transparency and the Drug Approval Process at Health Canada by : Ann Silversides
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 :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)
Book Synopsis The Role of NIH in Drug Development Innovation and Its Impact on Patient Access by : National Academies of Sciences, Engineering, and Medicine
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.
