Download or read book FDA Ensures Equivalence of Generic Drugs written by Jeffrey Yorke and published by . This book was released on 1993 with total page 6 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Approved Prescription Drug Products written by and published by . This book was released on 1981 with total page 16 pages. Available in PDF, EPUB and Kindle. Book excerpt: Accompanied by supplements.
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 523 pages. Available in PDF, EPUB and Kindle. Book excerpt: A NEW YORK TIMES BESTSELLER * New York Times Notable Book * Best Book of the Year: New York Public Library, Kirkus Reviews, Science Friday With a 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 Product Development written by Leon Shargel and published by CRC Press. This book was released on 2013-10-24 with total page 384 pages. Available in PDF, EPUB and Kindle. Book excerpt: In this era of increased pharmaceutical industry competition, success for generic drug companies is dependent on their ability to manufacture therapeutic-equivalent drug products in an economical and timely manner, while also being cognizant of patent infringement and other legal and regulatory concerns.Generic Drug Product Development: Solid Oral
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 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 Generic written by Jeremy A. Greene and published by Johns Hopkins University Press. This book was released on 2016-09-01 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.
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 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 Strategies Used by Adults to Reduce Their Prescription Drug Costs written by Robin A. Cohen and published by . This book was released on 2015 with total page 12 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Annual Report Food and Drug Administration written by United States. Food and Drug Administration and published by . This book was released on 1946 with total page 76 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book An Overview of FDA Regulated Products written by Eunjoo Pacifici and published by Academic Press. This book was released on 2018-06-13 with total page 292 pages. Available in PDF, EPUB and Kindle. Book excerpt: Today's challenge, especially for many newcomers to the regulated industry, is not necessarily to gather regulatory information, but to know how to interpret and apply it. The ability to discern what is important from what is not, and to interpret regulatory documents correctly, provides a valuable competitive advantage to any newcomer or established professional in this field. An Overview of FDA Regulated Products: From Drugs and Medical Devices to Food and Tobacco provides a valuable summary of the key information to unveil the meaning of critical, and often complex, regulatory concepts. Concise and easy to read with practical explanations, key points, summaries and case studies, this book highlights the regulatory processes involved in bringing an FDA regulated product from research and development to approval and market. Although the primary focus will be on the US system, this book also features global perspectives where appropriate. A valuable resource for students, professors and professionals, An Overview of FDA Regulated Products illustrates the most important elements and concepts so that the reader can focus on the critical issues and make the necessary connections to be successful. - Provides an overview of key regulatory requirements using a practical approach that features detailed discussions of hypothetical and real-world case studies in order to highlight the concepts and applications of regulations - Covers all FDA regulated products, including drugs, biologics, medical devices, cosmetics, foods, dietary supplements, cosmetics, veterinary products, tobacco and more in one single reference - Illustrates complex topics in a clear, succinct and engaging manner by breaking down technical terms and offering straightforward and easy to understand explanations
Download or read book Red Book written by Thomson and published by Wiley-Blackwell. This book was released on 2008 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: The new "2008 Red Book" not only presents the latest pricing and product information on more than 160,000 prescription and over-the-counter items, but also a complete list of newly FDA-approved brands, generics, and biologics.
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 In Vitro In Vivo Correlations written by David B. Young and published by Springer Science & Business Media. This book was released on 2013-03-08 with total page 299 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book represents the invited presentations and some of the posters presented at the conference entitled "In Vitro-In Vivo Relationship (IVIVR) Workshop" held in Sep tember, 1996. The workshop was organized by the IVIVR Cooperative Working Group which has drawn together scientists from a number of organizations and institutions, both academic and industrial. In addition to Elan Corporation, which is a drug delivery com pany specializing in the development of ER (Extended Release) dosage forms, the IVIVR Cooperative Working Group consists of collaborators from the University of Maryland at Baltimore, University College Dublin, Trinity College Dublin, and the University of Not tingham in the UK. The principal collaborators are: Dr. Jackie Butler, Elan Corporation Prof. Owen Corrigan, Trinity College Dublin Dr. lain Cumming, Elan Corporation Dr. John Devane, Elan Corporation Dr. Adrian Dunne, University College Dublin Dr. Stuart Madden, Elan Corporation Dr. Colin Melia, University of Nottingham Mr. Tom O'Hara, Elan Corporation Dr. Deborah Piscitelli, University of Maryland at Baltimore Dr. Araz Raoof, Elan Corporation Mr. Paul Stark, Elan Corporation Dr. David Young, University of Maryland at Baltimore The purpose of the workshop was to discuss new concepts and methods in the devel opment of in vitro-in vivo relationships for ER products. The original idea went back ap proximately 15 months prior to the workshop itself. For some time, the principal collaborators had been working together on various aspects of dosage form development.
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 Therapy for Severe Psoriasis E Book written by Jashin J. Wu and published by Elsevier Health Sciences. This book was released on 2016-12-02 with total page 217 pages. Available in PDF, EPUB and Kindle. Book excerpt: A brand-new title in the field of dermatology, Therapy for Severe Psoriasis provides the ultimate coverage of the treatment options available for today's most serious cases, including biologics and oral therapies. It features discussions of the newest drug therapies, recent FDA-approved biosimilars, and combination approaches to care, while an overview chapter was designed to aid those new to the field in understanding the nuances of difficult-to-treat subtypes of psoriasis. Comprehensive and focused, Therapy for Severe Psoriasis will be a welcome addition to the library of any dermatologist seeking in-depth information on the challenges of this condition. - Each of the 16 chapters includes either an in-depth focus on a single therapy or an overview of a unique aspect of psoriasis, including: UVB therapy, methotrexate, acitretin, cyclosporine, apremilast, etanercept, infliximab, adalimumab, ustekinumab, secukinumab, and ixekizumab. - Takes an evidence-based approach to hard-to-treat severe psoriasis. - Discusses the newest drug therapies (such as ixekizumab), plus recent FDA-approved biosimilars, a topic unique to this particular psoriasis text. - Presents combination approaches for instances when standard treatments are not successful. - Includes an overview chapter to help beginners understand the nuances of the disorder.
