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This resource equips transactional health care attorneys to adequately advise clients on fraud-and-abuse risks unique to this submarket of the health care industry. It breaks down the full legal and regulatory context of: off-label marketing; antitrust, securities law, and other compliance violations; reimbursement; civil and regulatory liability under securities and antitrust laws; compliance and corporate governance issues; and more.<p> </p>
Main Volume Information
2007/899 pp. Hardcover with 2014 Cumulative Supplement/Order #ABAWEB2323/$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.
2014 Cumulative Supplement alone: ISBN 9781617465093/Order #ABAWEB2509/$195.00
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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