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.

From Pharma to Device Sales
From Pharma to Device Sales

Author: Samuel D. Lamptey

Publisher: Troubador Publishing Ltd

Published: 2011-12-01

Total Pages: 105

ISBN-13: 1848767846

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From Pharma to Device Sales is a concise, straight to the point pocket guide, enabling pharmaceutical sales people to move into the medical device sales arena. There is no other book available that explores how to successfully change industries. This guide has valuable insights from recent personal experiences, up-to-date material and useful statistics – to ensure a successful industry transition. Making the switch from pharmaceutical sales to medical devices can be an uphill struggle. Are you in pharmaceutical sales looking to cross over? Have you ever wondered what selling medical devices is really like? Do you know the vital differences between selling drugs and devices? Do you want to know the typical mistakes pharmaceutical sales people make at interviews and learn how to avoid such pitfalls? This book will provide all these answers and much more! From Pharma to Device Sales is a unique, concise and inspirational book. Whatever stage you are at in your pharma career, this is a must read.

AHLA Pharmaceutical and Medical Device Compliance Manual (AHLA Members)
AHLA Pharmaceutical and Medical Device Compliance Manual (AHLA Members)

Author:

Publisher:

Published: 2016

Total Pages:

ISBN-13: 9780327175339

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The fight against fraud and abuse in healthcare programs, and the pharmaceutical and medical devices industry in particular, continues to grow. Since 1996 the federal government has strengthened its efforts to detect and prevent fraud and abuse in healthcare, and has recovered $18 billion since 1997. These enforcement activities make a compliance program essential to protecting a company from running afoul of the myriad laws and regulations that have been enacted to combat fraud and waste. Pharmaceutical and Medical Device Compliance Manual includes guidance to help companies do that.Coverage includes:In-depth coverage of the federal and state enforcement agenciesFederal Anti-Kickback Statute and False Claims Act detailsDistinction between manufacturers' lawful dissemination of scientific information and unlawful promotion of off-label useDiscussion of the Foreign Corrupt Practices Act and its extra-territorial reachCoverage and reimbursement of prescription drugs and medical devicesPrescription drug price regulationsThe Manual includes guidance on building an effective compliance program and will be a great tool for health and life sciences attorneys, compliance officers, and others in the pharmaceutical and medical devices industry.EDITORSKathleen M. Boozang, J.D., LL.M., Professor of Law, SETON HALL LAW, Center for Health & Pharmaceutical Law & Policy, Newark, NJSimone Handler-Hutchinson, J.D., Executive Director, SETON HALL LAW, Center for Health & Pharmaceutical Law & Policy, Newark, NJCONTRIBUTING AUTHORSBret A. Campbell, Esquire; Cadwalader, Wickersham & Taft LLP, Washington, DC; Sujata Dayal, Esquire; Biomet, Inc., Warsaw, IN; Michael Andre Donnella, Esquire; Wyeth, Madison, NJ; Katie Rose Fink, Esquire; U.S. Dept. of Health & Human Services, Office of Inspector General, Washington, DC; Brett R. Friedman, Esquire; Ropes & Gray, LLP, New York. NY; Gary F. Giampetruzzi, Esquire; Pfizer, Inc., New York, NY; Christopher R. Hall, Esquire; Saul Ewing, LLP, Philadelphia, PA; Patrick M. Hromisin, Esquire; Saul Ewing, LLP, Philadelphia, PA; Elizabeth H. Kim, Esquire; Porzio Life Sciences, LLC, Morristown, NJ; Daniel A. Kracov, Esquire; Arnold & Porter, LLP; Washington, DC; Bruce A. Levy, Esquire; Gibbons, PC., Newark, NJ; Ann E. Lewis, Esquire; Ropes & Gray, LLP, New York. NY; Benjamin S. Martin, Esquire; Epstein Becker & Green, PC, Washington, DC; Joseph W. Metro, Esquire; Reed Smith, LLP, Washington, DC; Lewis Morris, Esquire; U.S. Dept. of Health & Human Services, Office of Inspector General, Washington, DC; Kiaema R. Reid; Porzio Life Sciences, LLC, Morristown, NJ; Linda Pissott Reig, Esquire; Buchanan Ingersoll & Rooney, PC, Newark, NJ; Margaret Renner, Esquire; FDA (formerly Arnold & Porter), Silver Spring, MD; Mary Riordan, Esquire; U.S. Dept. of Health & Human Services, Office of Inspector General, Washington, DC; Lynn Shapiro Snyder, Esquire; Epstein Becker & Green, PC, Washington, DC; Brian Tretick; Athena Privacy, LLC, Washington, DC; Robert E. Wanerman, Esquire; Epstein Becker & Green, PC, Washington, DC; and Mara E. Zazzali-Hogan, Esquire, Gibbons, PC., Newark, NJ

FDA and Intellectual Property Strategies for Medical Device Technologies
FDA and Intellectual Property Strategies for Medical Device Technologies

Author: Gerald B. Halt

Publisher: Springer

Published: 2019-01-24

Total Pages: 333

ISBN-13: 3030044629

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This book offers comprehensive, easy to understand guidance for medical device technology innovators on how to work through the United States FDA regulatory review process, while also providing insight on the various intellectual property concerns that many medical device innovators face. In the first portion of this book, readers are introduced to important concepts concerning FDA compliance for medical devices, as well as strategies for successfully navigating the FDA regulatory review process. Specifically, the first portion discusses the expansive range of medical devices and then walks through the most common routes to market: the PMA and 510(k) application processes. In the second portion of this book, readers are introduced to the various types of intellectual property rights that are available for medical device technology inventions and innovations, and can explore ways to overcome unique intellectual property challenges faced by many medical device technology innovators. In the third portion of the book, specific strategies are discussed to navigate the interface between the FDA regulatory process and the process of obtaining intellectual property protection. This book also includes a number of descriptive examples, case studies and scenarios to illustrate the topics discussed, and is intended for use by medical device designers, developers and innovators.

Combination Products
Combination Products

Author: Smita Gopalaswamy

Publisher: CRC Press

Published: 2008-04-22

Total Pages: 168

ISBN-13: 1040068960

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The field of combination product development (products born of the integration of medical devices, biologics, and drugs) is so new that, while literature abounds on each part individually, there are very few publications, including FDA documents, available concerning the unique challenges posed by this nascent but fast-growing area. Providing

Innovation and the Pharmaceutical Industry
Innovation and the Pharmaceutical Industry

Author: H. Tristram Engelhardt

Publisher: M & M Scrivener Press

Published: 2014-05-14

Total Pages: 253

ISBN-13: 0980209471

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Innovation and the Pharmaceutical Industry: Critical Reflections on the Virtues of Profit examines the central role of profit in the development of pharmaceuticals, medical devices, and health care generally. Recent efforts to understand this role have often underestimated and even dismissed its importance, arguing for its replacement by other means and mechanisms. However, as the essays in this volume attest, it would be impossible to account adequately for the range of pharmaceuticals and medical devices that have become part of everyday medicine without recognizing that the depth and scope of innovations are tied not simply to altruism, a concern for the common good, or the pursuit of knowledge for its own sake, but crucially to the pursuit of private good and of individual profit. Balancing a concern for theory and practice, the analyses and evaluations provided in these essays touch directly on many of the most heated and important debates in pharmaceutical ethics, such as profit margins, corporate social responsibility, drug advertising, litigation, patents, and parallel trade. Reflecting critically on the problems and prospects of medical innovation, they invite a rethinking of the foundations of the bioethics and business ethics of the pharmaceutical and medical device industries by focusing on the long-term impact of policy decisions for human health and well-being.

Medical Device Regulatory Practices
Medical Device Regulatory Practices

Author: Val Theisz

Publisher: CRC Press

Published: 2015-08-03

Total Pages: 578

ISBN-13: 9814669113

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This book is intended to serve as a reference for professionals in the medical device industry, particularly those seeking to learn from practical examples and case studies. Medical devices, like pharmaceuticals, are highly regulated, and the bar is raised constantly as patients and consumers expect the best-quality healthcare and safe and effectiv