AHLA The Fundamentals of Life Sciences Law: Drugs, Devices, and Biotech, Second Edition (Non-Members)

American Health Lawyers Association

Publisher : American Health Lawyers Association

AHLA The Fundamentals of Life Sciences Law: Drugs, Devices, and Biotech, Second Edition (Non-Members)

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  • Format: softbound with CD, Print Book with CD ISBN: 9781630440152


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  • Format: Electronic book: epub ISBN: 9781630440176


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  • Format: Electronic book: mobi ISBN: 9781630440176


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Table of Contents Author/Contributors

Introduction/Preface/About the Editors and Authors
Chapter 1:   Introduction to the Regulation of drugs
Chapter 2:   Introduction to the regulation of Medical Devices
Chapter 3:   Introduction to the Regulation of Biologics
Chapter 4:   Regulation of Industry- Sponsored Clinical Trials
Chapter 5:   Key Federal Agencies: Roles and Responsibilities
Chapter 6:   Regulation of Advertising, Promotion, and Distribution of Drugs, Medical Devices and Biologics
Chapter 7:   Life Sciences: Fraud and Abuse
Chapter 8:   Antitrust Issues
Chapter 9:   Privacy Issues
Chapter 10:   State Regulation
Chapter 11:   Intellectual Property
Chapter 12:   Payment and Reimbursement Issues
Chapter 13:   International Issues
Chapter 14:   Life Sciences Transactions and Licensing

About the Author

American Health Lawyers Association (AHLA)

Leading health law to excellence through education, information, and dialogue, the American Health Lawyers Association (AHLA) is the nation's largest, nonpartisan, 501(c)(3) educational organization devoted to legal issues in the healthcare field. AHLA provides a wide variety of resources to address the issues faced by law firms, government, in-house counsel and academia and those who represent the entire spectrum of the health industry.

AHLA The Fundamentals of Life Sciences Law

Kristian A. Werling, Editor in Chief

Jeremy Alexander, Lauren Battaglia, Brian A. Bohnenkamp, Nancy E. Bonifant, Eve M. Brunts, Elizabeth Carder-Thompson, Carl H. Coleman, Susan A. Edwards, Paige Fillingame, David C. Gibbons, Daniel G. Gottlieb, Eric S. Greig, Simone Handler-Hutchinson, Clinton D. Hermes, Stuart S. Kurlander, Robert F. Leibenluft, Vicki L. Lung, Melissa L. Markey, Juliet M. McBride, Leigh L. Oliver, Jordan Paradise, Heather H. Pierce, Jennifer L. Pike, Preeya Noronha Pinto, Kelly N. "Nikki" Reeves, Corey W. Roush, Thomas J. Quinlan, Jason W. Saspin, Richard B. Smith, Judith Toffenetti, Susan L. Walker, and Constance A. Wilkinson

Jeffrey W. Brennan, Stefanie Doebler, Jennifer S. Geetter, Scott A. Memmott, Stephen J. Smith Jr, and Heather M. Zimmerman


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The Fundamentals of Life Sciences Law: Drugs, Devices, and Biotech, Second Edition, provides a solid grounding in the legal principles and issues inherent in this complex area. Both new practitioners and experienced attorneys alike will benefit from this unparalleled coverage.

This new edition features contributions from some of the most experienced and respected practitioners of life sciences and health law. Whether you're looking for an introduction to this area, or you need a go-to reference on your shelf, the coverage includes:

•  Regulation of Drugs
•  Regulation of Medical Devices
•  Regulation of Biologics
•  Clinical Trials
•  Fraud and Abuse
•  Federal Agencies
•  Regulation of Advertising, and Promotion of Drugs, Medical Devices, and Biologics
•  Antitrust
•  Privacy
•  State Regulation
•  Intellectual Property
•  Payment and Reimbursement
•  International Issues
•  Life Sciences Licensing Transaction