AHLA The Fundamentals of Life Sciences Law: Drugs, Devices, and Biotech (AHLA Members)
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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
• State Regulation
• Intellectual Property
• Payment and Reimbursement
• International Issues
• Life Sciences Licensing Transaction
EDITOR IN CHIEF:
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
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