Off Label Communications

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Off-label Communications

Mark Carlisle Levy
Off label Communications Book PDF

Author : Mark Carlisle Levy
Publisher : Unknown
Page : 217 pages
File Size : 43,6 Mb
Release : 2008
Category : Drugs
ISBN : 1935065033

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Off-label Communications by Mark Carlisle Levy Pdf

Drugs, biologics and devices increasingly are used to treat patients in ways that were not specifically approved by FDA. While FDA does not regulate off-label use nor forbid off-label prescribing, it does heavily regulate off-label promotion. This book provides comprehensive, practical advice on how to comply with those regulations. This guide gives a valuable historical perspective on off-label medicine. The authors discuss specific problems arising from off-label use and promotion, while providing practical instruction on how to deal with them, including: managing clinical trial disclosures; reimbursement; training and monitoring sales and marketing representatives; risk management; product liability litigation; ethical considerations and how the government is enforcing off-label sales and marketing compliance.

Promotion of FDA-regulated Medical Products

Joanne S. Hawana,Bethany J. Hills,Benjamin M. Zegarelli
Promotion of FDA regulated Medical Products Book PDF

Author : Joanne S. Hawana,Bethany J. Hills,Benjamin M. Zegarelli
Publisher : Unknown
Page : 185 pages
File Size : 47,5 Mb
Release : 2018
Category : Advertising
ISBN : OCLC:1122629906

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Promotion of FDA-regulated Medical Products by Joanne S. Hawana,Bethany J. Hills,Benjamin M. Zegarelli Pdf

Promotion of FDA-Regulated Medical Products is the update of the 2013 publication, FDA requirements for prescription drug promotion, by John Driscoll.

Legal and Forensic Medicine

Roy G. Beran
Legal and Forensic Medicine Book PDF

Author : Roy G. Beran
Publisher : Springer
Page : 0 pages
File Size : 44,7 Mb
Release : 2013-09-05
Category : Medical
ISBN : 3642323375

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Legal and Forensic Medicine by Roy G. Beran Pdf

This is a comprehensive reference text that examines the current state of Legal Medicine, which encompasses Forensic Medicine, in the 21st century. It examines the scope of both legal and forensic medicine, its application and study and has adopted a wide ranging approach including multinational authorship. It reviews the differences between and similarities of forensic and legal medicine, the need for academic qualification, the applications to many and varied fields including international aid, military medicine, health law and the application of medical knowledge to both criminal law and tort/civil law, sports medicine and law, gender and age related factors from obstetrics through to geriatrics and palliative care as well as cultural differences exploring the Christian/Judeo approach compared with that within Islamic cultures, Buddhism and Hinduism. The book looks at practical applications of legal medicine within various international and intercultural frameworks. This is a seminal authoritative text in legal and forensic medicine. It has a multi-author and multinational approach which crosses national boundaries. There is a great interest in the development of health law and legal medicine institutes around the world and this text comes in on the ground floor of this burgeoning discipline and provides the foundation text for many courses, both undergraduate and postgraduate. It defines the place of legal medicine as a specialized discipline.​

FDA in the Twenty-First Century

Holly Fernandez Lynch,I. Glenn Cohen
FDA in the Twenty First Century Book PDF

Author : Holly Fernandez Lynch,I. Glenn Cohen
Publisher : Columbia University Press
Page : 499 pages
File Size : 44,7 Mb
Release : 2015-09-08
Category : Business & Economics
ISBN : 9780231540070

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FDA in the Twenty-First Century by Holly Fernandez Lynch,I. Glenn Cohen Pdf

In its decades-long effort to assure the safety, efficacy, and security of medicines and other products, the Food and Drug Administration has struggled with issues of funding, proper associations with industry, and the balance between consumer choice and consumer protection. Today, these challenges are compounded by the pressures of globalization, the introduction of novel technologies, and fast-evolving threats to public health. With essays by leading scholars and government and private-industry experts, FDA in the Twenty-First Century addresses perennial and new problems and the improvements the agency can make to better serve the public good. The collection features essays on effective regulation in an era of globalization, consumer empowerment, and comparative effectiveness, as well as questions of data transparency, conflicts of interest, industry responsibility, and innovation policy, all with an emphasis on pharmaceuticals. The book also intervenes in the debate over off-label drug marketing and the proper role of the FDA before and after a drug goes on the market. Dealing honestly and thoroughly with the FDA's successes and failures, these essays rethink the structure, function, and future of the agency and the effect policy innovations may have on regulatory institutions abroad.

The Law of Off-label Uses of Medicines

Andrea Parziale
The Law of Off label Uses of Medicines Book PDF

Author : Andrea Parziale
Publisher : Taylor & Francis
Page : 183 pages
File Size : 55,9 Mb
Release : 2022-08-12
Category : Law
ISBN : 9781000634389

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The Law of Off-label Uses of Medicines by Andrea Parziale Pdf

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.

Ethics and the Pharmaceutical Industry

Michael A. Santoro,Thomas M. Gorrie
Ethics and the Pharmaceutical Industry Book PDF

Author : Michael A. Santoro,Thomas M. Gorrie
Publisher : Cambridge University Press
Page : 528 pages
File Size : 53,6 Mb
Release : 2005-10-31
Category : Business & Economics
ISBN : 9781139448574

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Ethics and the Pharmaceutical Industry by Michael A. Santoro,Thomas M. Gorrie Pdf

Despite the pharmaceutical industry's notable contributions to human progress, including the development of miracle drugs for treating cancer, AIDS, and heart disease, there is a growing tension between the industry and the public. Government officials and social critics have questioned whether the multibillion-dollar industry is fulfilling its social responsibilities. This doubt has been fueled by the national debate over drug pricing and affordable healthcare, and internationally by the battles against epidemic diseases, such as AIDS, in the developing world. Debates are raging over how the industry can and should be expected to act. The contributions in this book by leading figures in industry, government, NGOs, the medical community, and academia discuss and propose solutions to the ethical dilemmas of drug industry behavior. They examine such aspects as the role of intellectual property rights and patent protection, the moral and economic requisites of research and clinical trials, drug pricing, and marketing.

Model Rules of Professional Conduct

American Bar Association. House of Delegates,Center for Professional Responsibility (American Bar Association)
Model Rules of Professional Conduct Book PDF

Author : American Bar Association. House of Delegates,Center for Professional Responsibility (American Bar Association)
Publisher : American Bar Association
Page : 216 pages
File Size : 48,6 Mb
Release : 2007
Category : Law
ISBN : 1590318730

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Model Rules of Professional Conduct by American Bar Association. House of Delegates,Center for Professional Responsibility (American Bar Association) Pdf

The Model Rules of Professional Conduct provides an up-to-date resource for information on legal ethics. Federal, state and local courts in all jurisdictions look to the Rules for guidance in solving lawyer malpractice cases, disciplinary actions, disqualification issues, sanctions questions and much more. In this volume, black-letter Rules of Professional Conduct are followed by numbered Comments that explain each Rule's purpose and provide suggestions for its practical application. The Rules will help you identify proper conduct in a variety of given situations, review those instances where discretionary action is possible, and define the nature of the relationship between you and your clients, colleagues and the courts.

First Episode Psychosis

Katherine J. Aitchison,Robin M. Murray,Patrick J. Power,Eva M. Tsapakis
First Episode Psychosis Book PDF

Author : Katherine J. Aitchison,Robin M. Murray,Patrick J. Power,Eva M. Tsapakis
Publisher : CRC Press
Page : 152 pages
File Size : 48,6 Mb
Release : 2022-03-26
Category : Medical
ISBN : 9780429524141

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First Episode Psychosis by Katherine J. Aitchison,Robin M. Murray,Patrick J. Power,Eva M. Tsapakis Pdf

The new edition of this popular handbook has been thoroughly updated to include the latest data concerning treatment of first-episode patients. Drawing from their experience, the authors discuss the presentation and assessment of the first psychotic episode and review the appropriate use of antipsychotic agents and psychosocial approaches in effective management. This is an authoritative text written by a team of highly respected authors for psychiatrists, neurologists, primary care practitioners and health care professional working in psychiatry. Drawing from their experience, the presentation and assessment of the first psychotic episode are discussed, details regarding antipsychotic drugs and their appropriate use are reviewed and psychosocial approaches are examined. The resulting book offers a concise and valuable guide to those wishing to review the latest proposals for the treatment of first-episode psychosis supported by up-to-date references, in a single publication.

The Media and Communications Study Skills Student Guide

Doug Specht
The Media and Communications Study Skills Student Guide Book PDF

Author : Doug Specht
Publisher : University of Westminster Press
Page : 184 pages
File Size : 49,9 Mb
Release : 2020-11-25
Category : Education
ISBN : 9781912656578

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The Media and Communications Study Skills Student Guide by Doug Specht Pdf

All the tips, ideas and advice given to, and requested by, MA students in Media and Communications, are brought together in an easy-to-use accessible guide to help students study most effectively. Based upon many years of teaching study skills and hundreds of lecture slides and handouts this introduction covers a range of general and generic skills that the author relates specifically towards media and communications studies. As well as the mechanics of writing and presentations, the book also shows how students can work on and engage with the critical and contemplative elements of their degrees whilst retaining motivation and refining timekeeping skills. Of course the nuts and bolts of reading, writing, listening, seminars and the dreaded dissertation and essays are covered too. In addition advice on referencing, citation and academic style is offered for those with concerns over English grammar and expression. Aimed primarily at postgraduate students, there is significant crossover with undergraduate work, so this book will also prove of use to upper level undergraduate readers whether using English as a first or second language.

Nutrition and Integrative Medicine

Aruna Bakhru
Nutrition and Integrative Medicine Book PDF

Author : Aruna Bakhru
Publisher : CRC Press
Page : 1125 pages
File Size : 54,7 Mb
Release : 2018-08-06
Category : Medical
ISBN : 9781351649193

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Nutrition and Integrative Medicine by Aruna Bakhru Pdf

While medical professionals continue to practice traditional allopathic medicine, the public has turned toward nutritional and integrative medical therapies, especially for addressing the proliferation of chronic diseases. Written by leaders in the academic and scientific world, Nutrition and Integrative Medicine: A Primer for Clinicians presents various modalities to help restore health. This book provides users with a guide to evaluating and recommending nutritional and integrative therapies. The book offers insights on the microbiome of the human body, examines the relationship of human health to the microbiome of the food we ingest, and introduces the concept of "food as information." It provides enlightenment on anti-aging and healing modalities, mind–body medicine, and an investigation of psychological trauma as related to disease causation. Integrative therapies, including water, light, and sound therapy, are explored, and information on healing chronic disease through nutrition, the tooth–body connection, the role of toxins in disease causation, and electromagnetic field hypersensitivity, as well as its management, is presented.

CDC Yellow Book 2020

CENTERS FOR DISEASE CONTROL AND PREVENTION. (CDC)
CDC Yellow Book 2020 Book PDF

Author : CENTERS FOR DISEASE CONTROL AND PREVENTION. (CDC)
Publisher : Oxford University Press, USA
Page : 721 pages
File Size : 49,7 Mb
Release : 2019-06-11
Category : Medical
ISBN : 9780190065973

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CDC Yellow Book 2020 by CENTERS FOR DISEASE CONTROL AND PREVENTION. (CDC) Pdf

The definitive reference for travel medicine, updated for 2020! "A beloved travel must-have for the intrepid wanderer." -Publishers Weekly "A truly excellent and comprehensive resource." -Journal of Hospital Infection The CDC Yellow Book offers everything travelers and healthcare providers need to know for safe and healthy travel abroad. This 2020 edition includes: · Country-specific risk guidelines for yellow fever and malaria, including expert recommendations and 26 detailed, country-level maps · Detailed maps showing distribution of travel-related illnesses, including dengue, Japanese encephalitis, meningococcal meningitis, and schistosomiasis · Guidelines for self-treating common travel conditions, including altitude illness, jet lag, motion sickness, and travelers' diarrhea · Expert guidance on food and drink precautions to avoid illness, plus water-disinfection techniques for travel to remote destinations · Specialized guidelines for non-leisure travelers, study abroad, work-related travel, and travel to mass gatherings · Advice on medical tourism, complementary and integrative health approaches, and counterfeit drugs · Updated guidance for pre-travel consultations · Advice for obtaining healthcare abroad, including guidance on different types of travel insurance · Health insights around 15 popular tourist destinations and itineraries · Recommendations for traveling with infants and children · Advising travelers with specific needs, including those with chronic medical conditions or weakened immune systems, health care workers, humanitarian aid workers, long-term travelers and expatriates, and last-minute travelers · Considerations for newly arrived adoptees, immigrants, and refugees Long the most trusted book of its kind, the CDC Yellow Book is an essential resource in an ever-changing field -- and an ever-changing world.

Registers of Communication

Asif Agha,Frog
Registers of Communication Book PDF

Author : Asif Agha,Frog
Publisher : Suomalaisen Kirjallisuuden Seura
Page : 315 pages
File Size : 46,7 Mb
Release : 2015-12-03
Category : Social Science
ISBN : 9789522227980

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Registers of Communication by Asif Agha,Frog Pdf

In any society, communicative activities are organized into models of conduct that differentiate specific social practices from each other and enable people to communicate with each other in ways distinctive to those practices. The articles in this volume investigate a series of locale-specific models of communicative conduct, or registers of communication, through which persons organize their participation in varied social practices, including practices of politics, religion, schooling, migration, trade, media, verbal art, and ceremonial ritual. Drawing on research traditions on both sides of the Atlantic, the authors of these articles bring together insights from a variety of scholarly disciplines, including linguistics, anthropology, folklore, literary studies, and philology. They describe register models associated with a great many forms of interpersonal behavior, and, through their own multi-year and multi-disciplinary collaborative efforts, bring register phenomena into focus as features of social life in the lived experience of people in societies around the world.

Off-label Prescribing

David Cavalla
Off label Prescribing Book PDF

Author : David Cavalla
Publisher : John Wiley & Sons
Page : 211 pages
File Size : 50,7 Mb
Release : 2015-03-16
Category : Science
ISBN : 9781118912072

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Off-label Prescribing by David Cavalla Pdf

Today’s medicines are regulated for their efficacy and safety and, once approved, they can be marketed for certain uses as justified by the data. Regulatory bodies in developed countries are constituted by legal statute and operate as parts of government, ostensibly in the interests of the people as patients. But once approved, medicines can be used for any purpose the prescriber thinks fit and appropriate for the patient. One in five prescriptions is therefore written outside regulatory purview. Off-label Prescribing looks into the corners of our medicated lives, where drug regulation runs up against medical practice, and concerns the use of a drug that has been approved for one use (in medical parlance, ‘indication’) being used for a different indication; alternatively, being used on a different set of patients from the ones it is approved for, or at a different dose. Usually the patient is unaware of what is going on, having not been informed by their doctor of this aspect of his or her prescribing choice. The book examines how and why this occurs, what the various medical professions have to say about it, and how pharmaceutical companies benefit by moving into this poorly regulated area. Off-label Prescribing pulls these complex issues together in one volume, to highlight current practice, its advantages and weaknesses and how the author suggests practice should evolve in the future. It will therefore be of interest to all those who prescribe (and receive) medicines, combined with a greater objective to provide more transparency and discussion for professionals.

The Future of Drug Safety

Institute of Medicine,Board on Population Health and Public Health Practice,Committee on the Assessment of the US Drug Safety System
The Future of Drug Safety Book PDF

Author : Institute of Medicine,Board on Population Health and Public Health Practice,Committee on the Assessment of the US Drug Safety System
Publisher : National Academies Press
Page : 346 pages
File Size : 49,8 Mb
Release : 2007-02-27
Category : Medical
ISBN : 9780309133944

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The Future of Drug Safety by Institute of Medicine,Board on Population Health and Public Health Practice,Committee on the Assessment of the US Drug Safety System Pdf

In the wake of publicity and congressional attention to drug safety issues, the Food and Drug Administration (FDA) requested the Institute of Medicine assess the drug safety system. The committee reported that a lack of clear regulatory authority, chronic underfunding, organizational problems, and a scarcity of post-approval data about drugs' risks and benefits have hampered the FDA's ability to evaluate and address the safety of prescription drugs after they have reached the market. Noting that resources and therefore efforts to monitor medications' riskâ€"benefit profiles taper off after approval, The Future of Drug Safety offers a broad set of recommendations to ensure that consideration of safety extends from before product approval through the entire time the product is marketed and used.

The Oxford Handbook of U.S. Health Law

I. Glenn Cohen,Allison Hoffman,William M. Sage
The Oxford Handbook of U S Health Law Book PDF

Author : I. Glenn Cohen,Allison Hoffman,William M. Sage
Publisher : Oxford University Press
Page : 992 pages
File Size : 47,7 Mb
Release : 2016-11-18
Category : Law
ISBN : 9780199366538

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The Oxford Handbook of U.S. Health Law by I. Glenn Cohen,Allison Hoffman,William M. Sage Pdf

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.