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Author : Shashank Upadhye
Publisher :
ISBN 13 : 9780314991447
Total Pages : 643 pages
Book Rating : 4.9/5 (914 download)
Download or read book Generic Pharmaceutical Patent and FDA Law written by Shashank Upadhye and published by . This book was released on 2008 with total page 643 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Shashank Upadhye
Publisher :
ISBN 13 : 9780314649614
Total Pages : 0 pages
Book Rating : 4.6/5 (496 download)
Download or read book Generic Pharmaceutical Patent and FDA Law written by Shashank Upadhye and published by . This book was released on 2016 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Shashank Upadhye
Publisher :
ISBN 13 : 9780314927392
Total Pages : 796 pages
Book Rating : 4.9/5 (273 download)
Download or read book Generic Pharmaceutical Patent and FDA Law written by Shashank Upadhye and published by . This book was released on 2010 with total page 796 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Theodore Goldberg
Publisher :
ISBN 13 :
Total Pages : 584 pages
Book Rating : 4.:/5 (318 download)
Download or read book Generic Drug Laws written by Theodore Goldberg and published by . This book was released on 1986 with total page 584 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)
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.
Author : Katherine Eban
Publisher : HarperCollins
ISBN 13 : 0063054108
Total Pages : 512 pages
Book Rating : 4.0/5 (63 download)
Download or read book Bottle of Lies written by Katherine Eban and published by HarperCollins. This book was released on 2020-06-23 with total page 512 pages. Available in PDF, EPUB and Kindle. Book excerpt: A NEW YORK TIMES BESTSELLER New York Times 100 Notable Books of 2019 New York Public Library Best Books of 2019 Kirkus Reviews Best Health and Science Books of 2019 Science Friday Best Books of 2019 New postscript by the author From an award-winning journalist, an explosive narrative investigation of the generic drug boom that reveals fraud and life-threatening dangers on a global scale—The Jungle for pharmaceuticals Many have hailed the widespread use of generic drugs as one of the most important public-health developments of the twenty-first century. Today, almost 90 percent of our pharmaceutical market is comprised of generics, the majority of which are manufactured overseas. We have been reassured by our doctors, our pharmacists and our regulators that generic drugs are identical to their brand-name counterparts, just less expensive. But is this really true? Katherine Eban’s Bottle of Lies exposes the deceit behind generic-drug manufacturing—and the attendant risks for global health. Drawing on exclusive accounts from whistleblowers and regulators, as well as thousands of pages of confidential FDA documents, Eban reveals an industry where fraud is rampant, companies routinely falsify data, and executives circumvent almost every principle of safe manufacturing to minimize cost and maximize profit, confident in their ability to fool inspectors. Meanwhile, patients unwittingly consume medicine with unpredictable and dangerous effects. The story of generic drugs is truly global. It connects middle America to China, India, sub-Saharan Africa and Brazil, and represents the ultimate litmus test of globalization: what are the risks of moving drug manufacturing offshore, and are they worth the savings? A decade-long investigation with international sweep, high-stakes brinkmanship and big money at its core, Bottle of Lies reveals how the world’s greatest public-health innovation has become one of its most astonishing swindles.
Download or read book Generic Drug Laws written by and published by . This book was released on 1986 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Jeremy A. Greene
Publisher : JHU Press
ISBN 13 : 1421414945
Total Pages : 375 pages
Book Rating : 4.4/5 (214 download)
Download or read book Generic written by Jeremy A. Greene and published by JHU Press. This book was released on 2014-10-27 with total page 375 pages. Available in PDF, EPUB and Kindle. Book excerpt: The turbulent history of generic pharmaceuticals raises powerful questions about similarity and difference in modern medicine. Generic drugs are now familiar objects in clinics, drugstores, and households around the world. We like to think of these tablets, capsules, patches, and ointments as interchangeable with their brand-name counterparts: why pay more for the same? And yet they are not quite the same. They differ in price, in place of origin, in color, shape, and size, in the dyes, binders, fillers, and coatings used, and in a host of other ways. Claims of generic equivalence, as physician-historian Jeremy Greene reveals in this gripping narrative, are never based on being identical to the original drug in all respects, but in being the same in all ways that matter. How do we know what parts of a pill really matter? Decisions about which differences are significant and which are trivial in the world of therapeutics are not resolved by simple chemical or biological assays alone. As Greene reveals in this fascinating account, questions of therapeutic similarity and difference are also always questions of pharmacology and physiology, of economics and politics, of morality and belief. Generic is the first book to chronicle the social, political, and cultural history of generic drugs in America. It narrates the evolution of the generic drug industry from a set of mid-twentieth-century "schlock houses" and "counterfeiters" into an agile and surprisingly powerful set of multinational corporations in the early twenty-first century. The substitution of bioequivalent generic drugs for more expensive brand-name products is a rare success story in a field of failed attempts to deliver equivalent value in health care for a lower price. Greene’s history sheds light on the controversies shadowing the success of generics: problems with the generalizability of medical knowledge, the fragile role of science in public policy, and the increasing role of industry, marketing, and consumer logics in late-twentieth-century and early twenty-first century health care.
Author :
Publisher : U.S. Government Printing Office
ISBN 13 :
Total Pages : 94 pages
Book Rating : 4.:/5 (327 download)
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:
Author :
Publisher : DIANE Publishing
ISBN 13 : 1428951938
Total Pages : 129 pages
Book Rating : 4.4/5 (289 download)
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:
Author : New York State Consumer Protection Board
Publisher :
ISBN 13 :
Total Pages : 5 pages
Book Rating : 4.:/5 (885 download)
Download or read book The New York State Generic Drug Law Can Help You Save Money with the Same Quality Drugs written by New York State Consumer Protection Board and published by . This book was released on 1982 with total page 5 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Massachusetts. General Court. Science Resource Office
Publisher :
ISBN 13 :
Total Pages : 36 pages
Book Rating : 4.:/5 (15 download)
Download or read book How Effective are Generic Drug Laws? written by Massachusetts. General Court. Science Resource Office and published by . This book was released on 1980 with total page 36 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Robin Feldman
Publisher : Cambridge University Press
ISBN 13 : 131673949X
Total Pages : 165 pages
Book Rating : 4.3/5 (167 download)
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.
Author : United States. Congress. House. Committee on the Judiciary. Subcommittee on Courts, Civil Liberties, and the Administration of Justice
Publisher :
ISBN 13 :
Total Pages : 196 pages
Book Rating : 4.:/5 (319 download)
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:
Author : Theodore Goldberg
Publisher :
ISBN 13 :
Total Pages : pages
Book Rating : 4.:/5 (119 download)
Download or read book Generic Drug Laws$dA Decade of Trial - A Prescription for Progress written by Theodore Goldberg and published by . This book was released on 1986 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author :
Publisher :
ISBN 13 :
Total Pages : 20 pages
Book Rating : 4.3/5 (91 download)
Download or read book Approved Prescription Drug Products written by and published by . This book was released on 1984 with total page 20 pages. Available in PDF, EPUB and Kindle. Book excerpt: Accompanied by supplements.
Author : Donald O. Beers
Publisher : Wolters Kluwer
ISBN 13 : 1454836091
Total Pages : 2154 pages
Book Rating : 4.4/5 (548 download)
Download or read book Generic and Innovator Drugs written by Donald O. Beers and published by Wolters Kluwer. This book was released on 2013-05-22 with total page 2154 pages. Available in PDF, EPUB and Kindle. Book excerpt: Completely updated, the new Eighth Edition of Generic and Innovator Drugs: A Guide to FDA Approval Requirements provides indispensable and practical insights into the FDA approval process. Youand’ll find comprehensive coverage of: Abbreviated new drug applications 505(b)(2) new drug applications Delaying approval of competing products FDA approval of biologic drugs No other book can cover the drug approval process as thoroughly, answering important questions like these: What is required to extend the patent of an FDA-approved product? When must a generic manufacturer notify the innovator manufacturer when submitting an ANDA or 505(b)(2) application? When does the FDA delay approvals because of patent claims, and when does it ignore patents? How can one challenge an FDA exclusivity decision? When can a manufacturer safely sell a drug without prior FDA approval? In what circumstances can a generic manufacturer obtain FDA permission to file an ANDA for a variant of an existing drug? When will the FDA waive or reduce prescription drug user fees? How can a company or an individual avoid debarment? What steps are necessary to comply with the FDAand’s Fraud Policy? When and how can a drug company take advantage of FDA accelerated approval procedures? What are the labeling requirements for exporting approved drugs? How have the changes made by the FDA Safety and Innovation Act, including the Prescription Drug User Fee Act, the Generic Drug User Fee Amendments and the Biosimilars User Fee Act, and the Generating Antibiotic Incentives Now Act affected the overall statutory scheme? Generic and Innovator Drugs: A Guide to FDA Approval Requirements, Eighth Edition provides step-by-step guidance of the approval process and expert interpretation of: The Hatch-Waxman Act (Drug Price Competition and Patent Restoration Act) The Medicare Prescription Drug, Improvement, and Modernization Act The Food and Drug Administration Modernization Act The FDA Export Reform and Enhancement Act The Biologics Price Competition and Innovation Act And more! AUTHOR NOTE Donald O. Beersand’ contributions to this publication were completed before he rejoined the Food and Drug Administration. He has had no part in writing and revising this Eighth Edition.
