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Pharmaceutical Law: Regulation of Research, Development, and Marketing

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A Cumulative Supplement to this volume is now available. Order now

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2007/899 pp. Hardcover with 2014 Cumulative Supplement/Order #2303/$266.25

Pharmaceutical Law: Regulation of Research, Development, and Marketing is the only resource available that provides expert commentary and authoritative insights into a comprehensive range of pharmaceutical law issues. In fact, no other single volume discusses these complex issues in so much detail and offers the information required by transactional health care attorneys to adequately advise clients on the opportunities—and the liabilities—in this industry. This treatise addresses the considerable fraud-and-abuse risks unique to this submarket of the health care industry; covers off-label marketing—selling a drug for a purpose other than its intended use; and explains and discusses other hot risks areas, including the potential for antitrust, securities law, and other compliance violations.

The Medicare Part D drug benefit, coupled with the confusing and cumbersome methodology used for reimbursement, has added pressures to the already strained Medicare budget, increasing regulatory scrutiny and creating traps for the unwary and uninformed. Other increasingly important areas—including reimbursement and regulation, civil and regulatory liability under the securities and antitrust laws, and compliance and corporate governance issues—also are receiving increased attention from regulators.

Pharmaceutical Law: Regulation of Research, Development, and Marketing is a reference attorneys will turn to time and again for answers and guidance in all areas of pharmaceutical law.

 

Supplement Information

2014 Cumulative Supplement alone: ISBN 9781617465093/Order #2509/$260.00

The  2014 Cumulative Supplementincludes: extensive new discussion of the New Drug Application process; analysis of the FDA’s 2013 final guidance recommending risk-based approaches to clinical investigations monitoring by trial sponsors; Coverage of the Drug Quality and Security Act of 2013; review of DOJ 2013 and 2014 settlements in pharmaceutical cases; discussion of Anderson v. Peregrine Pharms., Inc., a securities class action for false and misleading statements about the effectiveness of an experimental drug; and other new developments.

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About the Editor-in-Chief
Michael E. Clark is Special Counsel with Duane Morris, LLP, Houston, Texas, and Adjunct Professor of Law at the University of Houston Law Center. Previously, he served as Chief of the Criminal Division of the U.S. Attorney’s Office for the Southern District of Texas. 
ABA Health Law Section


Supplement Information

Michael E. Clark, Editor-in-Chief, ABA Health Law Section

Main Volume Information

 2007/899 pp. Hardcover/ABAWEB1576


Supplement Information  

2014/Approx. 600 pp. Softcover/ABAWEB2509  

    Order 2014 Cumulative Supplement now.