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Review Of The Proposed Generic Drug And Biosimilars User Fees And Further Examination Of Drug Shortages
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Author :United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health Publisher : ISBN 13 : Total Pages :210 pages Book Rating :4.:/5 (319 download)
Book Synopsis Review of the Proposed Generic Drug and Biosimilars User Fees and Further Examination of Drug Shortages by : United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health
Download or read book Review of the Proposed Generic Drug and Biosimilars User Fees and Further Examination of Drug Shortages written by United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health and published by . This book was released on 2013 with total page 210 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author :United States. Congress Publisher :Createspace Independent Publishing Platform ISBN 13 :9781977841766 Total Pages :198 pages Book Rating :4.8/5 (417 download)
Book Synopsis Review of the Proposed Generic Drug and Biosimilars User Fees and Further Examination of Drug Shortages by : United States. Congress
Download or read book Review of the Proposed Generic Drug and Biosimilars User Fees and Further Examination of Drug Shortages written by United States. Congress and published by Createspace Independent Publishing Platform. This book was released on 2017-10 with total page 198 pages. Available in PDF, EPUB and Kindle. Book excerpt: Review of the proposed generic drug and biosimilars user fees and further examination of drug shortages : hearing before the Subcommittee on Health of the Committee on Energy and Commerce, House of Representatives, One Hundred Twelfth Congress, second session, February 9, 2012.
Author :United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health Publisher : ISBN 13 : Total Pages :0 pages Book Rating :4.:/5 (124 download)
Book Synopsis Review of the Proposed Generic Drug and Biosimilars User Fees and Further Examination of Drug Shortages by : United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health
Download or read book Review of the Proposed Generic Drug and Biosimilars User Fees and Further Examination of Drug Shortages written by United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health and published by . This book was released on 2013 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt:
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 Activity Report of the Committee on Energy and Commerce of the U.S. House of Representatives ... Together with Dissenting Views by : United States. Congress. House. Committee on Energy and Commerce
Download or read book Activity Report of the Committee on Energy and Commerce of the U.S. House of Representatives ... Together with Dissenting Views written by United States. Congress. House. Committee on Energy and Commerce and published by . This book was released on 2012 with total page 104 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Daily Digest written by and published by Government Printing Office. This book was released on with total page 566 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Congressional Record by : United States. Congress
Download or read book Congressional Record written by United States. Congress and published by . This book was released on with total page 2538 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Congressional Record is the official record of the proceedings and debates of the United States Congress. It is published daily when Congress is in session. The Congressional Record began publication in 1873. Debates for sessions prior to 1873 are recorded in The Debates and Proceedings in the Congress of the United States (1789-1824), the Register of Debates in Congress (1824-1837), and the Congressional Globe (1833-1873)
Book Synopsis Legislative Calendar by : United States. Congress. House. Committee on Energy and Commerce
Download or read book Legislative Calendar written by United States. Congress. House. Committee on Energy and Commerce and published by . This book was released on 2009 with total page 1064 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Congress and the Nation 2009-2012, Volume XIII by : Dave Tarr
Download or read book Congress and the Nation 2009-2012, Volume XIII written by Dave Tarr and published by CQ Press. This book was released on 2014-09-09 with total page 1105 pages. Available in PDF, EPUB and Kindle. Book excerpt: Chronicling the highly partisan and polarized environment during the historic first term of President Barack Obama, Congress and the Nation 2009-2012 Volume XIII is the most authoritative reference on congressional law-making and trends during the 111th and 112th Congresses. The newest edition in this award-winning series documents the most fiercely debated issues during this period, including: Stimulus spending in the wake of financial crisis The controversial reform of the U.S. healthcare system Showdowns over raising the national debt ceiling Extensions of tax cuts and unemployment compensation Confirmation of two new female members of the U.S. Supreme Court Overhaul of financial industry regulations Repeal of the “don’t ask, don’t tell” law banning openly gay armed forces personnel from military service This acclaimed resource also covers the shift in partisan control of the U.S. House after the 2010 midterm election and the subsequent gridlock for lawmaking in the 112th Congress. Organized by policy area, each chapter summarizes the legislative activity, including a chronology and legislative history of the bills passed and the major provisions of the final laws. No other source guides readers seamlessly through the policy output of the national legislature with the breadth, depth, and authority of Congress and the Nation. This must-have reference for all academic libraries meets the needs of the full spectrum of users, from lower-level undergraduates through researchers and faculty.
Book Synopsis Pharmaceutical Economics and Policy by : Stuart O. Schweitzer
Download or read book Pharmaceutical Economics and Policy written by Stuart O. Schweitzer and published by Oxford University Press. This book was released on 2018-05-01 with total page 352 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmaceuticals constitute a relatively small share of the total healthcare expenditure in most developed economies, and yet they play a critical role in the ongoing debate over how best to advance, improve, and afford healthcare. Despite this, and perhaps because of this, the industry has had, for many years, an outsized claim to fame and controversy, praise and criticisms, support and condemnation. Unfortunately, many participants in the debate do not fully understand the complexities of the industry and its role in the overall healthcare system. The analytical tools of economics provide a strong foundation for a better understanding of the dynamics of the pharmaceutical industry, its contribution to health and healthcare, its dual and often conflicting priorities of affordability and innovation, as well as the various private and public policy initiatives directed at the sector. This third edition of a uniquely comprehensive and balanced examination of the industry includes several new chapters on important topics such as the full-fledged generics sector, the arrival of biosimilars or generic biological drugs, the global consolidation of manufacturers, the evolving reimbursement landscape, and the emergence of the world's most populous nations, such as China, India, and Brazil, as both suppliers and consumers of pharmaceutical products. Other chapters have been fully rewritten or extensively updated, covering such important topics as the cost efficiency of research and development, pace of new innovations, economic evaluation and value-based pricing of drugs, and public and private interventions in the industry.
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.
Download or read book Congressional Record written by and published by . This book was released on with total page 1440 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author :United States. Congress. House. Committee on Appropriations. Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Publisher : ISBN 13 : Total Pages :454 pages Book Rating :4.3/5 ( download)
Book Synopsis Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations for 2016: Statements of interested individuals and organizations by : United States. Congress. House. Committee on Appropriations. Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies
Download or read book Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations for 2016: Statements of interested individuals and organizations written by United States. Congress. House. Committee on Appropriations. Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies and published by . This book was released on 2015 with total page 454 pages. Available in PDF, EPUB and Kindle. Book excerpt:
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...
Book Synopsis Advanced Statistics in Regulatory Critical Clinical Initiatives by : Wei Zhang
Download or read book Advanced Statistics in Regulatory Critical Clinical Initiatives written by Wei Zhang and published by CRC Press. This book was released on 2022-05-25 with total page 318 pages. Available in PDF, EPUB and Kindle. Book excerpt: Advanced Statistics in Regulatory Critical Clinical Initiatives is focused on the critical clinical initiatives introduced by the 21st Century Cure Act passed by the United States Congress in December 2016. The book covers everything from the outline of the initiatives to analysis on the effect on biopharmaceutical research and development. Advanced Statistics in Regulatory Critical Clinical Initiatives provides innovative ways to resolve common challenges in statistical research of rare diseases such small sample sizes and provides guidance for combined use of data. With analysis from regulatory and scientific perspectives this book is an ideal companion for researchers in biostatistics, pharmaceutical development, and policy makers in related fields. Key Features: Provides better understanding of innovative design and analysis of each critical clinical initiatives which may be used in regulatory review/approval of drug development. Makes recommendations to evaluate submissions accurately and reliably. Proposes innovative study designs and statistical methods for oncology and/or rare disease drug development. Provides insight regarding current regulatory guidance on drug development such as gene therapy and rare diseases.
Book Synopsis WHO guideline on country pharmaceutical pricing policies by :
Download or read book WHO guideline on country pharmaceutical pricing policies written by and published by World Health Organization. This book was released on 2020-09-29 with total page 70 pages. Available in PDF, EPUB and Kindle. Book excerpt: In recent years, high prices of pharmaceutical products have posed challenges in high- and low-income countries alike. In many instances, high prices of pharmaceutical products have led to significant financial hardship for individuals and negatively impacted on healthcare systems' ability to provide population-wide access to essential medicines. Pharmaceutical pricing policies need to be carefully planned, carried out, and regularly checked and revised according to changing conditions. Strong, well-thought-out policies can guide well-informed and balanced decisions to achieve affordable access to essential health products. This guideline replaces the 2015 WHO guideline on country pharmaceutical pricing policies, revised to reflect the growing body of literature since the last evidence review in 2010. This update also recognizes country experiences in managing the prices of pharmaceutical products.
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.
