A Practical Guide to FDA's Food and Drug Law and Regulation, Seventh Edition
A Practical Guide to FDA's Food and Drug Law and Regulation, Seventh Edition

Author: Stephen M. Kanovsky

Publisher:

Published: 2020-09

Total Pages: 672

ISBN-13: 9781935065876

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FDLI's popular reference book, A Practical Guide to FDA's Food and Drug Law and Regulation, Seventh Edition, provides an introduction to the laws and regulations governing development, marketing, and sale of FDA-regulated products, including topics on food, drugs, medical devices, biologics, dietary supplements, cosmetics, new animal drugs, cannabis, and tobacco and nicotine products. Structured to serve as a reference and as a teaching tool, the book offers practical legal and regulatory fundamentals, and each chapter builds sequentially from the last to provide an accessible overview of the key topics relevant to practitioners of food and drug law and regulation. This book is a standard legal text in law schools and graduate regulatory programs and has been cited as a reference in judicial opinions (including the U.S. Supreme Court). This Seventh Edition includes new sections on controlled substances, compounded drugs, and cannabis and cannabis-derived compounds. It also incorporates the latest amendments to the Federal Food, Drug, and Cosmetic Act, as well as FDA regulations and guidances.

Pharmaceutical and Biotech Patent Law
Pharmaceutical and Biotech Patent Law

Author: Arnold & Porter Kaye Scholer Llp

Publisher:

Published: 2019-06-07

Total Pages: 1204

ISBN-13: 9781402431388

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Pharmaceutical and Biotech Patent Law provides you with the legal, scientific, and technical information you need to help clients obtain, defend, and challenge patents in these important business areas. This practical guide shows you how to craft problem-free patent applications, including how to partner with the government to bring patented inventions quickly to the marketplace - invalidate competitors' patents by proving that they fail to meet key requirements - protect against various forms of patent infringement - and successfully rebut charges of infringement. It includes detailed checklists that help you resolve thorny patent problems in the complex pharmaceutical and biotech fields, and is regularly updated to reflect Federal Circuit rulings and other significant court decisions.

Dale and Appelbe's Pharmacy and Medicines Law
Dale and Appelbe's Pharmacy and Medicines Law

Author: Gordon E. Appelbe

Publisher: Pharmaceutical Press

Published: 2013

Total Pages: 609

ISBN-13: 0853699895

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This tenth edition of Dale and Appelbe's Pharmacy and Medicines Law, previously Dale and Appelbe's Pharmacy Law and Ethics, is your definitive guide to law relating to pharmacy and medicine practice in Great Britain. It covers law and professional regulation that all pharmacy and medicine professionals need to know.

The Law and Ethics of the Pharmaceutical Industry
The Law and Ethics of the Pharmaceutical Industry

Author: M.N.G. Dukes

Publisher: Elsevier

Published: 2005-11-04

Total Pages: 429

ISBN-13: 0080459366

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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

Contemporary Issues in Pharmaceutical Patent Law
Contemporary Issues in Pharmaceutical Patent Law

Author: Bryan Mercurio

Publisher: Taylor & Francis

Published: 2017-02-17

Total Pages: 258

ISBN-13: 1317389794

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This collection reflects on contemporary and contentious issues in international rulemaking in regards to pharmaceutical patent law. With chapters from both well-established and rising scholars, the collection contributes to the understanding of the regulatory framework governing pharmaceutical patents as an integrated discipline through the assessment of relevant laws, trends and policy options. Focusing on patent law and related pharmaceutical regulations, the collection addresses the pressing issues governments face in an attempt to resolve policy dilemmas involving competing interests, needs and objectives. The common theme running throughout the collection is the need for policy and law makers to think and act in a systemic manner and to be more reflective and responsive in finding new solutions within and outside the patent system to the long-standing problems as well as emerging challenges

Pharmacy Law Examination and Board Review
Pharmacy Law Examination and Board Review

Author: William Feinberg

Publisher: McGraw Hill Professional

Published: 2014-11-05

Total Pages: 545

ISBN-13: 0071829539

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Get your highest score possible on the MPJE® with detailed state-specific guidance! Complete coverage of 20 states, plus federal regulations! Pharmacy Law is the perfect way to prepare for the MPJE Exam. It delivers a rigorous review of pharmacy-related statutes, rules, and regulations that impact pharmacy practice in twenty states as well as a summary of federal regulations that pertain to pharmacy law. Federal coverage includes summaries of must-know legislation such as the Federal Controlled Substances Act, the Federal Food, Drug & Cosmetics Act, and other relevant federal guidelines. State-specific chapters discuss important topics such as renewal of pharmacists’ licenses, qualifications, prescription transfers, inventory requirements, record-keeping, and prescriptive authority. Each chapter concludes with practice scenarios and questions with appropriate explanations. The Review You Need to Excel in These States: Alabama, Arizona, Arkansas, California, Colorado, Florida, Georgia, Illinois, Indiana, Kentucky, Louisiana, Maryland, North Carolina, New Jersey, Ohio, Oregon, Pennsylvania, South Carolina, Texas & Wisconsin. Watch for future supplements with additional states.

Pharmaceutical Innovation, Competition and Patent Law
Pharmaceutical Innovation, Competition and Patent Law

Author: Josef Drexl

Publisher: Edward Elgar Publishing

Published: 2013-01-01

Total Pages: 347

ISBN-13: 0857932462

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Public health, safety and access to reasonably priced medicine are common policy goals of pharmaceutical regulations. As both the context for innovation and competitive structure change, industry actors dynamically challenge the balance between the incentive for protection and the achievement of those policy goals. Considering the arguments from the perspectives of innovation, competition law and patent law, this book explores the difficult question of balancing protection with access, highlighting the difficulties in harmonization and coordination. The contributors to this book, including academics, judges and practitioners from Europe, the US and Japan, explore to what extent patent strategies and life-cycle management practices take advantage of patent laws and health-care regulation and disrupt the necessary balance between incentives for innovation and access to affordable medicine and health care. Addressing fundamental questions in the field of pharmaceutical innovation, this book will appeal to scholars and practitioners in intellectual property, competition law and life sciences regulation, as well as pharmaceutical companies and regulators.