Generic And Innovator Drugs
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Generic And Innovator Drugs
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Author : Donald O. Beers
language : en
Publisher: Wolters Kluwer
Release Date : 2013-05-22
Generic And Innovator Drugs written by Donald O. Beers and has been published by Wolters Kluwer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013-05-22 with Law categories.
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.
Generic And Innovator Drugs
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Author : Donald O. Beers
language : en
Publisher:
Release Date : 1997
Generic And Innovator Drugs written by Donald O. Beers and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1997 with categories.
Generic And Innovator Drugs
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Author : Donald O. Beers
language : en
Publisher:
Release Date : 1995
Generic And Innovator Drugs written by Donald O. Beers and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1995 with Drugs categories.
How Increased Competition From Generic Drugs Has Affected Prices And Returns In The Pharmaceutical Industry
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Author :
language : en
Publisher: U.S. Government Printing Office
Release Date : 1998
How Increased Competition From Generic Drugs Has Affected Prices And Returns In The Pharmaceutical Industry written by and has been published by U.S. Government Printing Office this book supported file pdf, txt, epub, kindle and other format this book has been release on 1998 with Business & Economics categories.
Greater Access To Generic Drugs
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Author : Michelle Meadows
language : en
Publisher:
Release Date : 2003
Greater Access To Generic Drugs written by Michelle Meadows and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2003 with Drugs categories.
Generic
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Author : Jeremy A. Greene
language : en
Publisher: JHU Press
Release Date : 2014-10-27
Generic written by Jeremy A. Greene and has been published by JHU Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2014-10-27 with Medical categories.
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.
How Increased Competition From Generic Drugs Has Affected Prices And Returns In The Pharmaceutical Industry
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Author : Anna Cook
language : en
Publisher:
Release Date : 1998-11-01
How Increased Competition From Generic Drugs Has Affected Prices And Returns In The Pharmaceutical Industry written by Anna Cook and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1998-11-01 with categories.
Examines the extent to which competition from generic drugs has increased since 1984, when the Drug Price Competition & Patent Term Restoration Act (also known as the Hatch-Waxman Act) created an abbreviated approval process for generic prescription drugs & at the same time extended patent terms for innovator drugs. Also analyzes how that competition has affected the returns from developing a drug. Contents: the effect of managed care on the pharmaceutical market; pricing & competition in the pharmaceutical market; & the effects of the Hatch-Waxman act on the returns from innovation. Charts & tables.
Generic Drug Product Development
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Author : Leon Shargel
language : en
Publisher: CRC Press
Release Date : 2013-10-24
Generic Drug Product Development written by Leon Shargel and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013-10-24 with Medical categories.
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
Generic Drug Product Development
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Author : Isadore Kanfer
language : en
Publisher: CRC Press
Release Date : 2016-04-19
Generic Drug Product Development written by Isadore Kanfer and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-04-19 with Medical categories.
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
Generic Drugs
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Author : Ryan S. Blanton
language : en
Publisher:
Release Date : 2009
Generic Drugs written by Ryan S. Blanton and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2009 with Generic drugs categories.
The practice of "authorised generics" has recently been the subject of considerable attention by the pharmaceutical industry, regulators, and members of Congress alike. An "authorised generic" (sometimes termed a "branded", "flanking", or "pseudo" generic) is a pharmaceutical that is marketed by or on behalf of a brand name drug company, but is sold under a generic name. Although the availability of an additional competitor in the generic drug market would appear to be favourable to consumers, authorised generics have nonetheless proven controversial. Some observers believe that authorised generics potentially discourage independent generic firms both from challenging drug patents and from selling their own products. This book presents an analysis of the innovation and public health issues relating to authorised generic drugs. The book begins with a review of the procedures through which independent generic drug companies receive government permission to market their products and resolve patent disputes with brand-name firms. It also provides detailed background information pertaining to the concept of authorised generics and assesses their potential impact upon patent challenges and consumer welfare, as well as a summary of congressional issues and possible alternatives.