Orphan Drug Amendments Of 1991
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Orphan Drug Amendments Of 1991
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Author : United States. Congress. Senate. Committee on Labor and Human Resources
language : en
Publisher:
Release Date : 1992
Orphan Drug Amendments Of 1991 written by United States. Congress. Senate. Committee on Labor and Human Resources and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1992 with Law categories.
Orphan Drug Amendments Of 1991
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Author : United States. Congress. Senate. Committee on Labor and Human Resources
language : en
Publisher:
Release Date : 1992
Orphan Drug Amendments Of 1991 written by United States. Congress. Senate. Committee on Labor and Human Resources and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1992 with Law categories.
Rare Diseases And Orphan Products
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Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 2011-04-03
Rare Diseases And Orphan Products written by Institute of Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2011-04-03 with Medical categories.
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.
Anticompetitive Abuse Of The Orphan Drug Act
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Author : United States. Congress. Senate. Committee on the Judiciary. Subcommittee on Antitrust, Monopolies, and Business Rights
language : en
Publisher:
Release Date : 1992
Anticompetitive Abuse Of The Orphan Drug Act written by United States. Congress. Senate. Committee on the Judiciary. Subcommittee on Antitrust, Monopolies, and Business Rights and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1992 with Law categories.
Searching For Magic Bullets
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Author : Lisa A Basara
language : en
Publisher: CRC Press
Release Date : 1994-08-10
Searching For Magic Bullets written by Lisa A Basara and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 1994-08-10 with Science categories.
Searching for Magic Bullets reveals the quest of consumers, health professionals, and drug developers to find safer and faster methods of bringing new medications to the marketplace. Authors Basara and Montagne explore the current drug development and approval processes, their strengths and weaknesses, and the mechanisms by which patients and organizations evade these processes. Readers learn about the fundamentals of traditional and nontraditional drug discovery and development as they occur in the U.S., as well as the views of consumers, patients, and health professionals. Specific case studies of non-traditional drug development and acquisition strategies are highlighted, including AIDS medications, orphan drugs, and patient importation of medications. Basara and Montagne establish the differences in both knowledge and opinions of health consumers and health professionals regarding drug development, as well as how these differences often lead to frustration, dissatisfaction, and misappropriation of resources. The authors pinpoint the need for consumers and patients to know much more about the discovery and development of medicines, and for health professionals and students to understand patients’concerns, needs and beliefs, including their reasons for considering alternative methods of drug development and acquisition. Searching for Magic Bullets is a springboard from which consumers, health professionals, and students can discuss, debate, and resolve these issues and begin to develop more capable drug development and approval systems. This groundbreaking new book enlightens health professionals about patients’views regarding medication discovery and development and informs consumers and patients about the sometimes conflicting views of health professionals. It is divided into three sections: drug development and approval in the U.S., a case study of orphan drugs, and risky and sometimes illegal ways in which consumers evade the traditional drug development and approval systems. An Overview of the Chapters: A Review of the Drug Development Process of the Pharmaceutical Industry: Presents the steps that must be taken when researching and developing a new medication. The Food and Drug Administration and the Drug Approval Process: Describes the history and scope of the FDA, the steps involved in acquiring drug approval, and the various stages of clinical testing. Orphan Drug Legislation: A review of the Orphan Drug Act of 1983 and the changes that have recently been proposed by Congress. The impact of the Act is highlighted through a description of products that have been made available since the legislation was enacted. Issues of controversy are also highlighted. Non-traditional Methods of Drug Development: The role of patients and consumers in drug development and evaluation is discussed, with an emphasis on the perceived shortcomings of the formal system. Patient Influence on Drug Development and Regulation: The influence of patient advocacy groups and consumers is discussed in relation to the development and approval of orphan drugs, the fast-tracking of specific medications, and the use of unapproved and alternative therapies. Prescription Drug Importation: Clarifies the current drug importation regulations, as well as provides specific directions for patients wishing to receive such products or learn more about FDA importation laws. The final chapter summarizes safe and rational techniques that empower consumers in their search for beneficial drug therapies. Resources and strategies for obtaining and using information are provided as a reference for readers. A glossary of terms, acronyms, and a directory of supplemental information sources strengthens the reader's understanding of the information presented. Who Benefits From This Book? Consumers and patients can use Searching for Magic Bullets as an accurate source of information about significant but often confusing medical issues. The FDA and the way medications are developed are easily misunderstood, while alternative therapies and medication sources are often believed to be the only options. Patients will learn the viewpoints of the pharmaceutical industry, the government, and their health care professionals; the rationale for various steps in the drug development process; the risks and benefits of participation in clinical trials; how to obtain the highest quality care, make informed health decisions, and reduce health care costs; and finally, how to cope with a rare disease and/or limited access to approved medications. The result is an informed, influential, and active patient. For health professionals, this book reviews the steps of drug development and approval and provides explanations for drug development decisions; drug approval time lag; and patient frustrations, misinterpretations, and expectations. It is critical for health professionals to understand the needs of patients and to determine how they can work with patients to find acceptable solutions. The literature references and medical information sources are invaluable in this regard. Pharmaceutical industry executives, product managers, clinical researchers, and sales representatives will find a concise and timely examination of the ways in which medications are discovered, developed, marketed, and used by patients. Discussions of orphan drug development, biotechnology products, and patient issues may also provide new insights into these often misunderstood areas. Pharmacy, medical, nursing, and other students will find this book a consolidated reference source and guidebook for information about the primary issues surrounding drug development and the FDA approval process. Patients’knowledge of alternative medical therapies will only increase and health care curricula must include material that helps students understand patients’perceptions of the medication development and approval systems, as well as the importance of patients in health care decisionmaking. The disadvantages of current drug development and approval systems are described with the hope that future health professionals can amend these processes and ultimately enhance patient care.
Legislative Calendar One Hundred Second Congress
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Author : United States. Congress. Senate. Committee on Labor and Human Resources
language : en
Publisher:
Release Date : 1993
Legislative Calendar One Hundred Second Congress written by United States. Congress. Senate. Committee on Labor and Human Resources and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1993 with Legislative calendars categories.
Monthly Catalog Of United States Government Publications
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Author :
language : en
Publisher:
Release Date : 1990
Monthly Catalog Of United States Government Publications written by and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1990 with Government publications categories.
Pharmaceutical Dosage Forms
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Author : Kenneth E. Avis
language : en
Publisher: Routledge
Release Date : 2018-05-04
Pharmaceutical Dosage Forms written by Kenneth E. Avis and has been published by Routledge this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-05-04 with Medical categories.
Completely updated and enlarged to three volumes (originally published as two volumes), the Second Edition of Pharmaceutical Dosage Forms: Parenteral Medications examines every important aspect of sterile drug products. This volume (3) offers comprehensive coverage of medical devices, quality assurance and regulatory issues.;This in-depth reference and text: discusses regulatory requirements in record-keeping based on the US Food and Drug Administration's (FDA) Current Good Manufacturing Practices; places special emphasis on methods of detecting, counting and sizing particles; offers new perspectives on contemporary validation concepts and how they affect the validation process; explains current FDA enforcement activities, the voluntary compliance policy, select court cases, and how these relate to parenterals; provides recent materials on the use of audits as a means of verifying the efficacy of manufacturing control systems; highlights new US regulations for medical devices; and examines quality assurance, including new information on biological control tests for medical device materials.;With the contributions of leading experts, volume 3 of Pharmaceutical Dosage Forms: Parenteral Medications is intended as a day-to-day reference for pharmacists, medical device manufacturers, quality control and regulatory personnel, chemists and drug patent and litigation attorneys, as well as a text for upper-level undergraduate, graduate and continuing-education students in the pharmaceutical sciences.
Appropriating Technology
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Author : Ron Eglash
language : en
Publisher: U of Minnesota Press
Release Date : 2004
Appropriating Technology written by Ron Eglash and has been published by U of Minnesota Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2004 with Science categories.
From the vernacular engineering of Latino car design to environmental analysis among rural women to the production of indigenous herbal cures-groups outside the centers of scientific power persistently defy the notion that they are merely passive recipients of technological products and scientific knowledge. This is the first study of how such "outsiders" reinvent consumer products-often in ways that embody critique, resistance, or outright revolt.Contributors: Richard M. Benjamin, Miami U; Hank Bromley, SUNY, Buffalo; Massimiano Bucchi, U of Trento, Italy; Carmen M. Concepcin, U of Puerto Rico; Virginia Eubanks, Rensselaer Polytechnic Institute; Lisa Gitelman, Catholic U; David Albert Mhadi Goldberg, California College of Arts and Crafts; Samuel M. Hampton; Michael K. Heiman, Dickinson College; Linda Price King; Valerie Kuletz; Lisa Jean Moore, College of Staten Island, CUNY; Brian Martin Murphy, Niagra U; Paul Rosen, U of York; Michael Scarce, Peter Taylor, U of Massachusetts, Boston; Turtle Heart.Ron Eglash is assistant professor at Rensselaer Polytechnic Institute. Jennifer Croissant is associate professor at the University of California. Giovanna Di Chiro is assistant professor at Allegheny College. Rayvon Fouch is assistant professor at Rensselaer Polytechnic Institute.
Monthly Catalogue United States Public Documents
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Author :
language : en
Publisher:
Release Date : 1993
Monthly Catalogue United States Public Documents written by and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1993 with Government publications categories.