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

The Fundamentals of Life Sciences Law: Drugs, Devices, and Biotech provides a solid grounding in this complex area's legal principles and issues for both new and experienced attorneys.
Publisher: AHLA

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ISBN: 9781630440145
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ISBN: 9781630440169
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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 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

Kristian A. Werling

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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Published May, 2014.


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Table of contents


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