Distributing Scientific And Medical Publications On Unapproved New Uses Recommended Practices For Pharmaceuticals And Medical Devices

Author : Food and Drug Administration
Publisher : Independently Published
ISBN 13 : 9781797810829
Total Pages : 110 pages
Book Rating : 4.20/5 ( download)

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Download or read book Distributing Scientific and Medical Publications on Unapproved New Uses: Recommended Practices for Pharmaceuticals and Medical Devices written by Food and Drug Administration and published by Independently Published. This book was released on 2019-02-22 with total page 110 pages. Available in PDF, EPUB and Kindle. Book excerpt: This PRINT REPLICA contains the FDA guidance for industry on Distributing Scientific and Medical Publications on Unapproved New Uses dated February 2014, and the Food and Drug Administration Modernization Act of 1997. This is a revision of the guidance released in 2009 and is intended to clarify the ways in which a medical device manufacturer or pharmaceutical company or may use scientific and medical literature to promote its products, even if the literature doesn't conform to the FDA-approved uses for the product. This is a checklist that companies will need to consult for each instance of scientific and medical literature they wish to promote. These include medical and promotional interactions with health care professionals (HCP), Payer/Formulary Access Interactions, Publications, Grants And Continuing Medical Education (CME), Investigator Initiated Studies (IIS), and Post-Marketing Studies. According to the Executive Director of the Coalition for Healthcare Communication, John Kamp, "Manufacturers should be able to distribute truthful information - in the form of journal articles, medical textbooks and practice guidelines." Why buy a book you can download for free? We print this book so you don't have to. First you gotta find a good clean (legible) copy and make sure it's the latest version (not always easy). Some documents found on the web are missing some pages or the image quality is so poor, they are difficult to read. We look over each document carefully and replace poor quality images by going back to the original source document. We proof each document to make sure it's all there - including all changes. If you find a good copy, you could print it using a network printer you share with 100 other people (typically its either out of paper or toner). If it's just a 10-page document, no problem, but if it's 250-pages, you will need to punch 3 holes in all those pages and put it in a 3-ring binder. Takes at least an hour. It's much more cost-effective to just order the latest version from Amazon.com This book includes original commentary which is copyright material. Note that government documents are in the public domain. We print these large documents as a service so you don't have to. The books are compact, tightly-bound, full-size (8 1/2 by 11 inches), with large text and glossy covers. 4th Watch Publishing Co. is a HUBZONE SDVOSB. https: //usgovpub.com

Author : Andrea Parziale
Publisher : Taylor & Francis
ISBN 13 : 1000634388
Total Pages : 183 pages
Book Rating : 4.89/5 ( download)

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Download or read book The Law of Off-label Uses of Medicines written by Andrea Parziale and published by Taylor & Francis. This book was released on 2022-08-12 with total page 183 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book examines the regulatory framework for untested and unapproved uses (off-label uses) of medicines in the EU, UK, and USA. Before reaching patients, medicines are extensively tested by manufacturers and approved by regulators to minimise the risk of adverse reactions. However, physicians can prescribe pharmaceuticals for off-label uses, widespread in paediatrics, oncology, rare diseases and, more recently, in treatment for Covid-19. While off-label uses may offer hope, they may also expose patients to risks and uncertainties. Clarification is therefore needed to improve the protection of patients' rights while enhancing legal certainty for health actors. To this end, this work clarifies the regulatory mechanisms and litigation trends concerning off-licence prescriptions in these jurisdictions. It assesses how traditional, prevention-driven regulatory and civil liability rules are being adapted to tackle potential risks and scientific uncertainty. The book outlines the applicable regulations, as well as considering Brexit’s impact on off-label policies in the UK, and EU and national off-label policies in the context of the fight against the Covid-19 pandemic. It also explores under what conditions physicians, manufacturers, or regulators must compensate patients injured by untested prescriptions. The book will be an essential resource for researchers, academics and policy-makers working in the areas of medical law and ethics, public health law, pharmaceutical law and private comparative law.

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309042860
Total Pages : 241 pages
Book Rating : 4.64/5 ( download)

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Download or read book Modern Methods of Clinical Investigation written by Institute of Medicine and published by National Academies Press. This book was released on 1990-02-01 with total page 241 pages. Available in PDF, EPUB and Kindle. Book excerpt: The very rapid pace of advances in biomedical research promises us a wide range of new drugs, medical devices, and clinical procedures. The extent to which these discoveries will benefit the public, however, depends in large part on the methods we choose for developing and testing them. Modern Methods of Clinical Investigation focuses on strategies for clinical evaluation and their role in uncovering the actual benefits and risks of medical innovation. Essays explore differences in our current systems for evaluating drugs, medical devices, and clinical procedures; health insurance databases as a tool for assessing treatment outcomes; the role of the medical profession, the Food and Drug Administration, and industry in stimulating the use of evaluative methods; and more. This book will be of special interest to policymakers, regulators, executives in the medical industry, clinical researchers, and physicians.

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309158060
Total Pages : 442 pages
Book Rating : 4.60/5 ( download)

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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.

Author : Sarah E. Boslaugh
Publisher : SAGE Publications
ISBN 13 : 1483349993
Total Pages : 1883 pages
Book Rating : 4.92/5 ( download)

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Download or read book The SAGE Encyclopedia of Pharmacology and Society written by Sarah E. Boslaugh and published by SAGE Publications. This book was released on 2015-09-15 with total page 1883 pages. Available in PDF, EPUB and Kindle. Book excerpt: The SAGE Encyclopedia of Pharmacology and Society explores the social and policy sides of the pharmaceutical industry and its pervasive influence in society. While many technical STM works explore the chemistry and biology of pharmacology and an equally large number of clinically oriented works focus on use of illegal drugs, substance abuse, and treatment, there is virtually nothing on the immensely huge business (“Big Pharma”) of creating, selling, consuming, and regulating legal drugs. With this new Encyclopedia, the topic of socioeconomic, business and consumer, and legal and ethical issues of the pharmaceutical industry in contemporary society around the world are addressed. Key Features: 800 signed articles, authored by prominent scholars, are arranged A-to-Z and published in a choice of electronic or print formats Although arranged A-to-Z, a Reader's Guide in the front matter groups articles by thematic areas Front matter also includes a Chronology highlighting significant developments in this field All articles conclude with Further Readings and Cross References to related articles Back matter includes an annotated Resource Guide to further research, a Glossary, Appendices (e.g., statistics on the amount and types of drugs prescribed, etc.), and a detailed Index The Index, Reader’s Guide, and Cross References combine for search-and-browse capabilities in the electronic edition The SAGE Encyclopedia of Pharmacology and Society is an authoritative and rigorous source addressing the pharmacology industry and how it influences society, making it a must-have reference for all academic libraries as a source for both students and researchers to utilize.

Author : Michael Cheng
Publisher : World Health Organization
ISBN 13 : 9241546182
Total Pages : 54 pages
Book Rating : 4.88/5 ( download)

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Download or read book Medical Device Regulations written by Michael Cheng and published by World Health Organization. This book was released on 2003-09-16 with total page 54 pages. Available in PDF, EPUB and Kindle. Book excerpt: The term 'medical devices' covers a wide range of equipment essential for patient care at every level of the health service, whether at the bedside, at a health clinic or in a large specialised hospital. Yet many countries lack access to high-quality devices, particularly in developing countries where health technology assessments are rare and there is a lack of regulatory controls to prevent the use of substandard devices. This publication provides a guidance framework for countries wishing to create or modify their own regulatory systems for medical devices, based on best practice experience in other countries. Issues highlighted include: the need for harmonised regulations; and the adoption, where appropriate, of device approvals of advanced regulatory systems to avoid an unnecessary drain on scarce resources. These approaches allow emphasis to be placed on locally-assessed needs, including vendor and device registration, training and surveillance and information exchange systems.

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309186501
Total Pages : 95 pages
Book Rating : 4.06/5 ( download)

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Download or read book Medical Countermeasures Dispensing written by Institute of Medicine and published by National Academies Press. This book was released on 2010-12-16 with total page 95 pages. Available in PDF, EPUB and Kindle. Book excerpt: During public health emergencies such as terrorist attacks or influenza outbreaks, the public health system's ability to save lives could depend on dispensing medical countermeasures such as antibiotics, antiviral medications, and vaccines to a large number of people in a short amount of time. The IOM's Forum on Medical and Public Health Preparedness for Catastrophic Events held a workshop on November 18, 2009, to provide an overview of current threats, recent progress made in the public health system for distributing and dispensing countermeasures, and remaining vulnerabilities.

Author : I. Glenn Cohen
Publisher : Oxford University Press
ISBN 13 : 0190250038
Total Pages : 992 pages
Book Rating : 4.34/5 ( download)

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Download or read book The Oxford Handbook of U.S. Health Law written by I. Glenn Cohen and published by Oxford University Press. This book was released on 2016-11-18 with total page 992 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Oxford Handbook of U.S. Health Law covers the breadth and depth of health law, with contributions from the most eminent scholars in the field. The Handbook paints with broad thematic strokes the major features of American healthcare law and policy, its recent reforms including the Affordable Care Act, its relationship to medical ethics and constitutional principles, and how it compares to the experience of other countries. It explores the legal framework for the patient experience, from access through treatment, to recourse (if treatment fails), and examines emerging issues involving healthcare information, the changing nature of healthcare regulation, immigration, globalization, aging, and the social determinants of health. This Handbook provides valuable content, accessible to readers new to the subject, as well as to those who write, teach, practice, or make policy in health law.

Author : National Research Council and Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309041473
Total Pages : 206 pages
Book Rating : 4.78/5 ( download)

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Download or read book Developing New Contraceptives written by National Research Council and Institute of Medicine and published by National Academies Press. This book was released on 1990-01-01 with total page 206 pages. Available in PDF, EPUB and Kindle. Book excerpt: There are numerous reasons to hasten the introduction of new and improved contraceptivesâ€"from health concerns about the pill to the continuing medical liability crisis. Yet, U.S. organizations are far from taking a leadership position in funding, researching, and introducing new contraceptivesâ€"in fact, the United States lags behind Europe and even some developing countries in this field. Why is research and development of contraceptives stagnating? What must the nation do to energize this critical arena? This book presents an overall examination of contraceptive development in the United Statesâ€"covering research, funding, regulation, product liability, and the effect of public opinion. The distinguished authoring committee presents a blueprint for substantial change, with specific policy recommendations that promise to gain the attention of specialists, the media, and the American public. The highly readable and well-organized volume will quickly become basic reading for legislators, government agencies, the pharmaceutical industry, private organizations, legal professionals, and researchersâ€"everyone concerned about family planning, reproductive health, and the impact of the liability and regulatory systems on scientific innovations.

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 030904491X
Total Pages : 225 pages
Book Rating : 4.12/5 ( download)

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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.