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Prescription Drug User Fee Act Of 1992
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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 Pathway to Global Product Safety and Quality by : Margaret A. Hamburg
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.
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 Assuring Data Quality and Validity in Clinical Trials for Regulatory Decision Making by : Institute of Medicine
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.
Book Synopsis How Increased Competition from Generic Drugs Has Affected Prices and Returns in the Pharmaceutical Industry by :
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:
Book Synopsis Frontiers in Health Policy Research by : David M. Cutler
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.
Book Synopsis The Future of Drug Safety by : Institute of Medicine
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.
Book Synopsis Pharmacy Practice and The Law by : Richard Abood
Download or read book Pharmacy Practice and The Law written by Richard Abood and published by Jones & Bartlett Learning. This book was released on 2011 with total page 474 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Sixth Edition of this best-selling text includes updates to account for new legal, regulatory and policy developments. Pharmacy Practice and the Law, Sixth Edition provides background, history and discussion of the law so as to enable the student to not only learn the facts, but to help them understand, apply and critically evaluate the information. The issues covered in this text are discussed in non-legal, easy to understand language. Challenging open-ended discussion questions and edited cases are included in every chapter to facilitate discussion and critical thinking. Citations to all laws, court cases, regulations and other documents are provided. An online instructor’s manual is available. Pharmacy Practice and the Law, Sixth Edition, is a useful resource both for teaching the facts of pharmacy law and for stimulating critical thinking issues in pharmacy law.
Author :United States. Congress. House. Committee on Commerce. Subcommittee on Health and the Environment Publisher : ISBN 13 : Total Pages :140 pages Book Rating :4.0/5 ( download)
Book Synopsis Reauthorization of the Prescription Drug User Fee Act and FDA Reform by : United States. Congress. House. Committee on Commerce. Subcommittee on Health and the Environment
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:
Book Synopsis Marijuana and Medicine by : Institute of Medicine
Download or read book Marijuana and Medicine written by Institute of Medicine and published by National Academies Press. This book was released on 1999-07-10 with total page 288 pages. Available in PDF, EPUB and Kindle. Book excerpt: The medical use of marijuana is surrounded by a cloud of social, political, and religious controversy, which obscures the facts that should be considered in the debate. This book summarizes what we know about marijuana from evidence-based medicineâ€"the harm it may do and the relief it may bring to patients. The book helps the reader understand not only what science has to say about medical marijuana but also the logic behind the scientific conclusions. Marijuana and Medicine addresses the science base and the therapeutic effects of marijuana use for medical conditions such as glaucoma and multiple sclerosis. It covers marijuana's mechanism of action, acute and chronic effects on health and behavior, potential adverse effects, efficacy of different delivery systems, analysis of the data about marijuana as a gateway drug, and the prospects for developing cannabinoid drugs. The book evaluates how well marijuana meets accepted standards for medicine and considers the conclusions of other blue-ribbon panels. Full of useful facts, this volume will be important to anyone interested in informed debate about the medical use of marijuana: advocates and opponents as well as policymakers, regulators, and health care providers.
Book Synopsis Pharmacy Practice and the Law by : Richard R. Abood
Download or read book Pharmacy Practice and the Law written by Richard R. Abood and published by Jones & Bartlett Learning. This book was released on 2005 with total page 408 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmacy Practice and the Law creates a solid overview of pharmacy law, incorporating relevant case laws and historical backgrounds of why and how specific laws developed. The new Fourth Edition stimulates critical thinking issues in pharmacy law and explains the federal and state pharmacy regulation that corresponds to recent directives of the American Association of Colleges of Pharmacy. This text serves as a tool to pass the law portion of a board examination, and helps students develop as practitioners, contributors andleaders to the profession itself.
Book Synopsis Orphans and Incentives by : Institute of Medicine
Download or read book Orphans and Incentives written by Institute of Medicine and published by National Academies Press. This book was released on 1997-10-30 with total page 112 pages. Available in PDF, EPUB and Kindle. Book excerpt: Infectious diseases remain a leading cause of prolonged illness, premature mortality, and soaring health costs. In the United States in 1995, infectious diseases were the third leading cause of death, right behind heart disease and cancer. Mortality is mounting over time, owing to HIV/AIDS, pneumonia, and septicemia, with drug resistance playing an ever-increasing role in each of these disease categories. This book, a report from a Forum on Emerging Infections workshop, focuses on product areas where returns from the market might be perceived as being too small or too complicated by other factors to compete in industrial portfolios with other demands for investment. Vaccines are quintessential examples of such products. The lessons learned fall into four areas, including what makes intersectoral collaboration a reality, the notion of a product life cycle, the implications of divergent sectoral mandates and concepts of risk, and the roles of advocacy and public education. The summary contains an examination of the Children's Vaccine Initiative and other models, an industry perspective on the emerging infections agenda, and legal and regulatory issues.
Author :United States. General Accounting Office Publisher :DIANE Publishing ISBN 13 :1428942831 Total Pages :63 pages Book Rating :4.4/5 (289 download)
Book Synopsis Prescription drugs OxyContin abuse and diversion and efforts to address the problem : report to congressional requesters. by : United States. General Accounting Office
Download or read book Prescription drugs OxyContin abuse and diversion and efforts to address the problem : report to congressional requesters. written by United States. General Accounting Office and published by DIANE Publishing. This book was released on 2003 with total page 63 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author :United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health Publisher : ISBN 13 : Total Pages :132 pages Book Rating :4.0/5 ( download)
Book Synopsis Reauthorization of the Prescription Drug User Fee Act by : United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health
Download or read book Reauthorization of the Prescription Drug User Fee Act written by United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health and published by . This book was released on 2002 with total page 132 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Encyclopedia of Health Economics by :
Download or read book Encyclopedia of Health Economics written by and published by Newnes. This book was released on 2014-02-21 with total page 1663 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Encyclopedia of Health Economics offers students, researchers and policymakers objective and detailed empirical analysis and clear reviews of current theories and polices. It helps practitioners such as health care managers and planners by providing accessible overviews into the broad field of health economics, including the economics of designing health service finance and delivery and the economics of public and population health. This encyclopedia provides an organized overview of this diverse field, providing one trusted source for up-to-date research and analysis of this highly charged and fast-moving subject area. Features research-driven articles that are objective, better-crafted, and more detailed than is currently available in journals and handbooks Combines insights and scholarship across the breadth of health economics, where theory and empirical work increasingly come from non-economists Provides overviews of key policies, theories and programs in easy-to-understand language
Book Synopsis Enhancing the Regulatory Decision-Making Approval Process for Direct Food Ingredient Technologies by : Institute of Medicine
Download or read book Enhancing the Regulatory Decision-Making Approval Process for Direct Food Ingredient Technologies written by Institute of Medicine and published by National Academies Press. This book was released on 1999-04-29 with total page 158 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Institute of Medicine's (IOM's) Food Forum was established in 1993 to allow science and technology leaders in the food industry, top administrators in the federal government, representatives from consumer interest groups, and academicians to discuss and debate food and food safety issues openly and in a neutral setting. The Forum provides a mechanism for these diverse groups to identify possible approaches for addressing food and food safety problems and issues surrounding the often complex interactions among industry, academia, regulatory agencies, and consumers. On May 6-7, 1997, the Forum convened a workshop titled Enhancing the Regulatory Decision-Making Process for Direct Food Ingredient Technologies. Workshop speakers and participants discussed legal aspects of the direct food additive approval process, changes in science and technology, and opportunities for reform. Two background papers, which can be found in Appendix A and B, were shared with the participants prior to the workshop. The first paper provided a description and history of the legal framework of the food ingredient approval process and the second paper focused on changes in science and technology practices with emphasis placed on lessons learned from case studies. This document presents a summary of the workshop.
Book Synopsis Research and Development in the Pharmaceutical Industry (A CBO Study) by : Congressional Budget Office
Download or read book Research and Development in the Pharmaceutical Industry (A CBO Study) written by Congressional Budget Office and published by Lulu.com. This book was released on 2013-06-09 with total page 65 pages. Available in PDF, EPUB and Kindle. Book excerpt: Perceptions that the pace of new-drug development has slowed and that the pharmaceutical industry is highly profitable have sparked concerns that significant problems loom for future drug development. This Congressional Budget Office (CBO) study-prepared at the request of the Senate Majority Leader-reviews basic facts about the drug industry's recent spending on research and development (R&D) and its output of new drugs. The study also examines issues relating to the costs of R&D, the federal government's role in pharmaceutical research, the performance of the pharmaceutical industry in developing innovative drugs, and the role of expected profits in private firms' decisions about investing in drug R&D. In keeping with CBO's mandate to provide objective, impartial analysis, the study makes no recommendations. David H. Austin prepared this report under the supervision of Joseph Kile and David Moore. Colin Baker provided valuable consultation...
