Download or read book Generic drug entry prior to patent expiration an FTC study written by and published by DIANE Publishing. This book was released on 2002 with total page 129 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book The Waxman Report written by Henry Waxman and published by Twelve. This book was released on 2009-07-02 with total page 151 pages. Available in PDF, EPUB and Kindle. Book excerpt: At a time when some of the most sweeping national initiatives in decades are being debated, Congressman Henry Waxman offers a fascinating inside account of how Congress really works by describing the subtleties and complexities of the legislative process. For four decades, Waxman has taken visionary and principled positions on crucial issues and been a driving force for change. Because of legislation he helped champion, our air is cleaner, our food is safer, and our medical care better. Thanks to his work as a top watchdog in Congress, crucial steps have been taken to curb abuses on Wall Street, to halt wasteful spending in Iraq, and to ban steroids from Major League Baseball. Few legislators can match his accomplishments or his insights on how good work gets done in Washington. In this book, Waxman affords readers a rare glimpse into how this is achieved-the strategy, the maneuvering, the behind-the-scenes deals. He shows how the things we take for granted (clear information about tobacco's harmfulness, accurate nutritional labeling, important drugs that have saved countless lives) started out humbly-derided by big business interests as impossible or even destructive. Sometimes, the most dramatic breakthroughs occur through small twists of fate or the most narrow voting margin. Waxman's stories are surprising because they illustrate that while government's progress may seem glacial, much is happening, and small battles waged over years can yield great results. At a moment when so much has been written about what's wrong with Congress-the grid, the partisanship, the influence of interest groups-Henry Waxman offers sophisticated, concrete examples of how government can (and should) work.

Download or read book Drug Wars written by Robin Feldman and published by Cambridge University Press. This book was released on 2017-06-09 with total page 165 pages. Available in PDF, EPUB and Kindle. Book excerpt: While the shockingly high prices of prescription drugs continue to dominate the news, the strategies used by pharmaceutical companies to prevent generic competition are poorly understood, even by the lawmakers responsible for regulating them. In this groundbreaking work, Robin Feldman and Evan Frondorf illuminate the inner workings of the pharmaceutical market and show how drug companies twist health policy to achieve goals contrary to the public interest. In highly engaging prose, they offer specific examples of how generic competition has been stifled for years, with costs climbing into the billions and everyday consumers paying the price. Drug Wars is a guide to the current landscape, a roadmap for reform, and a warning of what is to come. It should be read by policymakers, academics, patients, and anyone else concerned with the soaring costs of prescription drugs.

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.

Download or read book Generic Animal Drug and Patent Term Restoration Act written by United States. Congress. House. Committee on the Judiciary. Subcommittee on Courts, Civil Liberties, and the Administration of Justice and published by . This book was released on 1989 with total page 196 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Generic Drug Product Development written by Isadore Kanfer and published by CRC Press. This book was released on 2016-04-19 with total page 334 pages. Available in PDF, EPUB and Kindle. Book excerpt: Due to a worldwide need for lower cost drug therapy, use of generic and multi-source drug products have been increasing. To meet international patent and trade agreements, the development and sale of these products must conform to national and international laws, and generic products must prove that they are of the same quality and are therapeutica

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 Drug Price Competition and Patent Term Restoration Act of 1984 written by United States. Congress. Senate. Committee on Labor and Human Resources and published by . This book was released on 1984 with total page 382 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book A Fire Upon The Deep written by Vernor Vinge and published by Tor Science Fiction. This book was released on 2010-04-01 with total page 626 pages. Available in PDF, EPUB and Kindle. Book excerpt: Now with a new introduction for the Tor Essentials line, A Fire Upon the Deep is sure to bring a new generation of SF fans to Vinge's award-winning works. A Hugo Award-winning Novel! “Vinge is one of the best visionary writers of SF today.”-David Brin Thousands of years in the future, humanity is no longer alone in a universe where a mind's potential is determined by its location in space, from superintelligent entities in the Transcend, to the limited minds of the Unthinking Depths, where only simple creatures, and technology, can function. Nobody knows what strange force partitioned space into these "regions of thought," but when the warring Straumli realm use an ancient Transcendent artifact as a weapon, they unwittingly unleash an awesome power that destroys thousands of worlds and enslaves all natural and artificial intelligence. Fleeing this galactic threat, Ravna crash lands on a strange world with a ship-hold full of cryogenically frozen children, the only survivors from a destroyed space-lab. They are taken captive by the Tines, an alien race with a harsh medieval culture, and used as pawns in a ruthless power struggle. Tor books by Vernor Vinge Zones of Thought Series A Fire Upon The Deep A Deepness In The Sky The Children of The Sky Realtime/Bobble Series The Peace War Marooned in Realtime Other Novels The Witling Tatja Grimm's World Rainbows End Collections Collected Stories of Vernor Vinge True Names At the Publisher's request, this title is being sold without Digital Rights Management Software (DRM) applied.

Download or read book New Drug Development Science Business Regulatory Intellectual Property Issues Cited as Hampering Drug Development Efforts written by United States Government Accountability Office and published by DIANE Publishing. This book was released on 2006 with total page 54 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book The Changing Economics of Medical Technology written by Institute of Medicine and published by National Academies Press. This book was released on 1991-02-01 with total page 225 pages. Available in PDF, EPUB and Kindle. Book excerpt: Americans praise medical technology for saving lives and improving health. Yet, new technology is often cited as a key factor in skyrocketing medical costs. This volume, second in the Medical Innovation at the Crossroads series, examines how economic incentives for innovation are changing and what that means for the future of health care. Up-to-date with a wide variety of examples and case studies, this book explores how payment, patent, and regulatory policiesâ€"as well as the involvement of numerous government agenciesâ€"affect the introduction and use of new pharmaceuticals, medical devices, and surgical procedures. The volume also includes detailed comparisons of policies and patterns of technological innovation in Western Europe and Japan. This fact-filled and practical book will be of interest to economists, policymakers, health administrators, health care practitioners, and the concerned public.

Download or read book ANDA Litigation written by Kenneth L. Dorsney and published by American Bar Association. This book was released on 2012 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Examining the intersection between the statutory and regulatory scheme governing approval of generic pharmaceuticals and U.S. patent law in the context of Paragraph IV ANDA litigation, this comprehensive guide focuses on current and developing law as well as litigation strategies and tactics. This ready roadmap begins with an explanation of the Hatch-Waxman Act, its implementation, and litigation. Other topics include preparing and trying the case, post-trial issues and appeals, remedies, settlement, antitrust implications, and litigation of pharmaceuticals outside the U.S.

Download or read book Pharmaceutical Patent Law written by John R. Thomas and published by BNA Books (Bureau of National Affairs). This book was released on 2005 with total page 714 pages. Available in PDF, EPUB and Kindle. Book excerpt: "Appendix" is included in the CD-ROM.

Download or read book Food and Drug Regulation written by ADAM I. MUCHMORE and published by . This book was released on 2021-03-14 with total page 734 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Intellectual Property Rights and Capital Formation in the Next Decade written by American Council for Capital Formation. Center for Policy Research and published by . This book was released on 1988 with total page 218 pages. Available in PDF, EPUB and Kindle. Book excerpt: Intellectual property rightsócopyrights, patents, trademarksóare crucial to innovation and the creation of new technologies. In this volume, leading experts, policymakers, academics, corporate representativesóset out to broaden awareness of the linkages between intellectual property rights and U.S. competitiveness. Sections include: The Role of Intellectual Property Rights in Capital Formation and Economic Growth; Reconciling Intellectual Property Rights Issues Among Developed and Less Developed Countries; Capital Formation, Competitiveness, and Intellectual Property Rights; Industry Perspectives on the International Protection of Intellectual Property Rights; The New GATT Round and Intellectual Property Rights. Co-published with the American Council for Capital Formation Center for Policy Research.

Download or read book Food and Drug Law written by Peter Barton Hutt and published by . This book was released on 1991 with total page 1454 pages. Available in PDF, EPUB and Kindle. Book excerpt: This casebook provides detailed information on legal aspects food and drug law. The casebook provides the tools for fast, easy, on-point research. Part of the University Casebook Series®, it includes selected cases designed to illustrate the development of a body of law on a particular subject. Text and explanatory materials designed for law study accompany the cases.

Download or read book The Legislative History of the Drug Price Competition and Patent Term Restoration Act of 1984 written by Allan M. Fox and published by . This book was released on 1987 with total page 570 pages. Available in PDF, EPUB and Kindle. Book excerpt: