Law And The Regulation Of Medicines

Law and the Regulation of Medicines PDF
Author: Emily Jackson
Publisher: Bloomsbury Publishing
Category : Law
Languages : en
Pages : 308
View: 2948

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Book Description:
The principal purpose of this book is to tell the story of a medicine's journey through the regulatory system in the UK, from defining what counts as a medicine, through clinical trials, licensing, pharmacovigilance, marketing and funding. The question of global access to medicines is addressed because of its political importance, and because it offers a particularly stark illustration of the consequences of classifying medicines as a private rather than a public good. Two further specific challenges to the future of medicine's regulation are examined separately: first, pharmacogenetics, or the genetic targeting of medicines to subgroups of patients, and second, the possibility of using medicines to enhance well-being or performance, rather than treat disease. Throughout, the emphasis is on the role of regulation in shaping and influencing the operation of the medicines industry, an issue that is of central importance to the promotion of public health and the fair and equitable distribution of healthcare resources.


The Law And Regulation Of Medicines

The Law and Regulation of Medicines PDF
Author: Peter Feldschreiber
Publisher: Oxford University Press, USA
Category : Law
Languages : en
Pages : 473
View: 1400

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Book Description:
This is a comprehensive textbook on the science, regulatory policy and law surrounding the discovery, development and marketing of new medicines. It is designed as a reference work for legal, medical and pharmaceutical professionals working in the fields of medicine regulation, medical law and product liability. The authors are a group of specialists in pharmaceutical medicine, pharmacology and therapeutics and lawyers specialising in product liability law andintellectual property. Serving as a practical introduction for practitioners wishing to undertake work in this highly complex area of law, this book is specifically designed to facilitate deeper mutual understanding of the technical issues for the lawyer and the legal issues for those involved withregulatory policy and decision making.


Food And Drug Law

Food and Drug Law PDF
Author: Roseann B. Termini
Publisher:
Category : Law
Languages : en
Pages : 557
View: 4689

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Book Description:
Purpose and OverviewThis comprehensive "All-in-One" book titled: "Food and Drug Law: Federal Regulation of Drugs, Biologics, Medical Devices, Foods, Dietary Supplements, Personal Care, Veterinary and Tobacco Products Regulation is organized for ease of reading in order to comprehend a complex area of law. There is a separately titled volume contained in this book for each subject based on the regulation under the United States Federal Food, Drug and Cosmetic Act (FDCA) and related law. It is an especially valuable resource for:The regulated industry such as legal counsel and regulatory affairs professionals searching for concise explanations of relevant portions of the Food, Drug and Cosmetic Act (FDCA); Legal practitioners whose practice involves food, medical devices, drugs, biologics, personal care, veterinary, dietary supplements and tobacco products regulatory law;Government personnel--federal, state and local involved in these topics; Attorneys in related disciplines who find themselves in the crosshairs of the FDCA; andThe academic community including professors and students searching for a clear resource. Each title contained in this "All-in-One" resource starts with a concise introduction to provide a particular focus for the reader as follows:Volume I: The "Why" of the United States Food and Drug Administration, Landmark Legislation, and Court Decisions Volume II: Food and Drug Law Administrative Primer Volume III: The Food and Drug Administration--Criminal and Civil Enforcement StrategiesVolume IV: Medical Device and Radiation Emitting Products RegulationVolume V: Human Drug Regulation--Approvals, Promotion, Marketing, Warnings, Accountability, and Postmarket SurveillanceVolume VI: Biotechnology and Biologic Products RegulationVolume VII: Veterinary Products RegulationVolume VIII: Personal Care Products Regulation--Safety, Product Classification and EnforcementVolume IX: Food Regulation--Food Safety, Recalls, Claims, Additives, Allergens and BiotechnologyVolume X: Dietary Supplements, Herbs and Botanicals RegulationVolume XI: Tobacco Products RegulationVolume XII: Professionalism, Politics, Foreign Corrupt Practices, Product Classification, Globalization and the Future


Australian Pharmacy Law And Practice

Australian Pharmacy Law and Practice PDF
Author: John Low
Publisher: Elsevier Australia
Category : Law
Languages : en
Pages : 226
View: 399

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Book Description:
Addresses the current issues surrounding pharmacy law and regulation in Australia. Provides a comprehensive analysis and discussion of the legislation and practice standards relevant to the practice of pharmacy. Low, University of Queensland; Forrester, Bond University; Hattingh, Griffith University.


The Law And Ethics Of The Pharmaceutical Industry

The Law and Ethics of the Pharmaceutical Industry PDF
Author: M.N.G. Dukes
Publisher: Elsevier
Category : Medical
Languages : en
Pages : 422
View: 4034

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Book Description:
As one of the most massive and successful business sectors, the pharmaceutical industry is a potent force for good in the community, yet its behaviour is frequently questioned: could it serve society at large better than it has done in the recent past? Its own internal ethics, both in business and science, may need a careful reappraisal, as may the extent to which the law - administrative, civil and criminal - succeeds in guiding (and where neccessary contraining) it. The rules of behavior that may be considered to apply to today's pharmaceutical industry have emerged over a very long period and the process goes on. Even the immensely detailed standards for quality, safety and efficacy laid down in drug law and regulation during the second half of the twentieth century have their limitations as tools for ensuring that the public interest is well served. In particular, national and regional regulatory agencies are heavily dependent on industrial data for their decision-making, their standards and competence vary, and even the existing network of agencies does not cover the entire world. What is more there are many areas of law and regulation affecting the industry, concerning for example the pricing of medicines, the conduct of clinical studies, the health protection of workers and concern for the environment. In some fields it is indeed hardly possible to maintain standards through regulation. Professor N.M. Graham Dukes, a physician and lawyer with long term experience in industrial research management, academic study and international drug policy, provides here a powerfully documented analysis into the way this industry thinks, acts, and is viewed, and examines the current trends pointing to change. *Provides a balanced picture of the current role of the pharmaceutical industry in society *Includes indices of conventions, laws, and regulations; as well as judicial and disciplinary cases *This is the only book addressing the legal implications of big pharma activities and ethical standards