Download or read book The Future of Drug Safety written by Institute of Medicine and published by National Academies Press. This book was released on 2007-03-27 with total page 347 pages. Available in PDF, EPUB and Kindle. Book excerpt: In the wake of publicity and congressional attention to drug safety issues, the Food and Drug Administration (FDA) requested the Institute of Medicine assess the drug safety system. The committee reported that a lack of clear regulatory authority, chronic underfunding, organizational problems, and a scarcity of post-approval data about drugs' risks and benefits have hampered the FDA's ability to evaluate and address the safety of prescription drugs after they have reached the market. Noting that resources and therefore efforts to monitor medications' riskâ€"benefit profiles taper off after approval, The Future of Drug Safety offers a broad set of recommendations to ensure that consideration of safety extends from before product approval through the entire time the product is marketed and used.
Download or read book Frontiers in Health Policy Research written by David M. Cutler and published by MIT Press. This book was released on 2004 with total page 196 pages. Available in PDF, EPUB and Kindle. Book excerpt: Leading economists discuss current health policy challenges, including prescription drugs benefits as a component of Medicare and conversion to for-profit health plans.
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.
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.
Download or read book How Increased Competition from Generic Drugs Has Affected Prices and Returns in the Pharmaceutical Industry written by and published by U.S. Government Printing Office. This book was released on 1998 with total page 94 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Assuring Data Quality and Validity in Clinical Trials for Regulatory Decision Making written by Institute of Medicine and published by National Academies Press. This book was released on 1999-07-27 with total page 88 pages. Available in PDF, EPUB and Kindle. Book excerpt: In an effort to increase knowledge and understanding of the process of assuring data quality and validity in clinical trials, the IOM hosted a workshop to open a dialogue on the process to identify and discuss issues of mutual concern among industry, regulators, payers, and consumers. The presenters and panelists together developed strategies that could be used to address the issues that were identified. This IOM report of the workshop summarizes the present status and highlights possible strategies for making improvements to the education of interested and affected parties as well as facilitating future planning.
Download or read book Reauthorization of the Prescription Drug User Fee Act and FDA Reform written by United States. Congress. House. Committee on Commerce. Subcommittee on Health and the Environment and published by . This book was released on 1997 with total page 140 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Understanding Health Outcomes and Pharmacoeconomics written by George E. MacKinnon III and published by Jones & Bartlett Publishers. This book was released on 2011-09-22 with total page 241 pages. Available in PDF, EPUB and Kindle. Book excerpt: Understanding Health Outcomes and Pharmacoeconomics presents an overview of the tools used to assess patient-related health status including associated health outcomes and the analyses that are used to determine cost-effectiveness in evaluating pharmacotherapeutic interventions to improve health. Including data and examples from several different countries, this comprehensive text will help students understand the basis for decisions made at the local and governmental level that impact the use of pharmaceuticals and provide a strong foundation for understanding the principles used in cost-effective decision making. With commentaries, cases studies, and highlighting international differences, this text concludes with a discussion of the need for a universal system for documenting medication use. Understanding Health Outcomes and Pharmacoeconomics provides definitions of comparative effectiveness research (CER) and comparisons of pharmacoeconomic models (including cost-effectivess, cost-benefit, and cost utility analyses). This inclusive text provides describes how CER is linked to various pharmacoeconomic models by providing examples from clinical trials with comparative pharmacotherapy and cost parameters. From the Introduction: "The need for interprofessional education was made apparent in the 2003 Health Professions Education: A Bridge to Quality report. All healthcare professionals must be educated to deliver patient-centered care as members of an interprofessional team, emphasizing evidence-based practice, quality improvement approaches, and informatics. An enhanced understanding of pharmacoeconomic principles is a step in the right direction for healthcare practitioners as we do our best to ensure optimal medication therapy outcomes for patients and society at-large." -- George E. MacKinnon III, PhD, RPh, FASHP
Download or read book Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease written by Institute of Medicine and published by National Academies Press. This book was released on 2010-06-25 with total page 335 pages. Available in PDF, EPUB and Kindle. Book excerpt: Many people naturally assume that the claims made for foods and nutritional supplements have the same degree of scientific grounding as those for medication, but that is not always the case. The IOM recommends that the FDA adopt a consistent scientific framework for biomarker evaluation in order to achieve a rigorous and transparent process.
Download or read book Evaluating the Effectiveness of the Food And Drug Administration Modernization Act written by United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health and published by . This book was released on 2001 with total page 172 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Assessing the Safety of Our Nation s Drug Supply written by United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health and published by . This book was released on 2008 with total page 200 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Pathway to Global Product Safety and Quality written by Margaret A. Hamburg and published by DIANE Publishing. This book was released on 2012-10-07 with total page 37 pages. Available in PDF, EPUB and Kindle. Book excerpt: This report presents a new strategy by the Food and Drug Admin. (FDA) to meet the challenges posed by rapidly rising imports of FDA-regulated products and a complex global supply chain. The agency is planning to transform the way it conducts business and to act globally in order to promote and protect the health of U.S. consumers. Highlights of the report include four key elements needed to make the change: (1) The FDA will partner with its counterparts worldwide to create global coalitions of regulators focused on ensuring and improving global product safety and quality; (2) The coalitions of regulators will develop international data information systems and networks and increase the regular and proactive sharing of data and regulatory resources across world markets; (3) The FDA will build in additional information gathering and analysis capabilities with an increased focus on risk analytics and IT; (4) The FDA increasingly will leverage the efforts of public and private third parties and industry and allocate FDA resources based on risk. The report also discusses trends expected to be seen worldwide in upcoming years which have caused FDA to develop its new strategy. Figures. This is a print on demand report.
Download or read book Prescription drugs many factors affected FDA s approval of selected pipeline drugs report to congressional requesters written by and published by DIANE Publishing. This book was released on with total page 58 pages. Available in PDF, EPUB and Kindle. Book excerpt:
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.
Download or read book Peptide Therapeutics written by Ved Srivastava and published by Royal Society of Chemistry. This book was released on 2019-08-28 with total page 572 pages. Available in PDF, EPUB and Kindle. Book excerpt: Peptide therapy has become a key strategy in innovative drug development, however, one of the potential barriers for the development of novel peptide drugs in the clinic is their deficiencies in clearly defined chemistry, manufacturing and controls (CMC) strategy from clinical development to commercialization. CMC can often become a rate-limiting step due to lack of knowledge and lack of a formal policy or guidelines on CMC for peptide-based drugs. Regulators use a risk-based approach, reviewing applications on a case-by-case basis. Peptide Therapeutics: Strategy and Tactics for Chemistry, Manufacturing, and Controls covers efficient manufacturing of peptide drug substances, a review of the process for submitting applications to the regulatory authority for drug approval, a holistic approach for quality attributes and quality control from a regulatory perspective, emerging analytical tools for the characterisation of impurities, and the assessment of stability. This book is an essential reference work for students and researchers, in both academia and industry, with an interest in learning about CMC, and facilitating development and manufacture of peptide-based drugs.
Download or read book Medical Innovation in the Changing Healthcare Marketplace written by National Research Council and published by National Academies Press. This book was released on 2002-05-06 with total page 92 pages. Available in PDF, EPUB and Kindle. Book excerpt: A wave of new health care innovation and growing demand for health care, coupled with uncertain productivity improvements, could severely challenge efforts to control future health care costs. A committee of the National Research Council and the Institute of Medicine organized a conference to examine key health care trends and their impact on medical innovation. The conference addressed the following question: In an environment of renewed concern about rising health care costs, where can public policy stimulate or remove disincentives to the development, adoption and diffusion of high-value innovation in diagnostics, therapeutics, and devices?
Download or read book The Oxford Handbook of the Economics of the Biopharmaceutical Industry written by Patricia M. Danzon and published by OUP USA. This book was released on 2012-04-24 with total page 618 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume examines the economics of the biopharmaceutical industry, with eighteen chapters by health economists.
