Navigation Links
BNA Books Announces the Publication of the 2011 Cumulative Supplement to "Pharmaceutical Law: Regulation of Research, Development, and Marketing"
Date:1/10/2012

ARLINGTON, Va., Jan. 10, 2012 /PRNewswire-USNewswire/ -- BNA Books, a division of specialized news and information publisher BNA, today announces the publication of the 2011 Cumulative Supplement to Pharmaceutical Law: Regulation of Research, Development, and Marketing, providing important updates on securities cases and developments involving fraud and abuse, HIPAA, and the FDA. The treatise is one of the many ABA/BNA publications available from BNA Books.

(Logo: http://photos.prnewswire.com/prnh/20120110/DC33627LOGO)

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. 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.

The 2011 Cumulative Supplement includes discussion of:

  • The indictment of an FDA chemist for insider trading
  • Foreign Corrupt Practices Act enforcement action against Johnson & Johnson related to unlawful payments and kickbacks
  • The renewed importance of the Responsible Corporate Officer Doctrine
  • The 2010 Amendments to the Organizational Sentencing Guidelines and their impact on how companies can benefit by structuring their compliance programs in specific ways
  • The HITECH Act and its various requirements, including breach notification, restrictions on remuneration for PHI, and penalties
  • The heightened emphasis on HIPAA Enforcement
  • The Future of FDA Regulatory Authority and the FDA's Initiatives for 2011–2015
  • The expansion of FDA authority by Title VII of PPACA and the Biologics Price Competition and Innovation Act of 2009 (BPCIA) 

The treatise was published in cooperation with the ABA Health Law Section. Section publications provide a balanced forum for the views and professional development of practitioners in health law. For more information on Section participation, please call the Section at 312.988.5824 or visit www.americanbar.org/groups/health_law.html.

The editor-in-chief of Pharmaceutical Law: Regulation of Research, Development, and Marketing, 2011 Supplement is Michael E. Clark, Special Counsel with Duane Morris, LLP, Houston, TX, and Adjunct Professor of Law at the University of Houston Law Center, who previously served as Chief of the Criminal Division of the U.S. Attorney's Office for the Southern District of Texas.

BNA, a wholly-owned subsidiary of Bloomberg L.P., is a leading source of legal, regulatory, and business information for professionals. In addition to Pharmaceutical Law: Regulation of Research, Development, and Marketing, BNA's Book Division publishes: E-Health, Privacy, and Security Law; Health Care Fraud and Abuse: Practical Perspectives; Managed Care Litigation; Prosecuting and Defending Health Care Fraud Cases; and other titles in health law. For a free BNA Books catalog, call 1.800.960.1220, send an e-mail request to books@bna.com, or visit us online at www.bna.com/bnabooks.  

Pharmaceutical Law: Regulation of Research, Development, and Marketing, 2011 Supplement may be purchased alone (Order #1995-PR11/$230.00 plus tax, shipping, and handling) or with the main volume (Order #9995-PR11/$485.00 plus tax, shipping, and handling) from BNA Books, PO Box 7814, Edison, NJ 08818-7814. Telephone orders: 1.800.960.1220. Fax orders: 1.732.346.1624. A 10% discount is available on print copies of books when ordering from the website at www.bna.com/bnabooks.  Please note that discounts cannot be combined.

Editors: Review copy available upon request.
Please e-mail Matt Greene at mgreene@bna.com, or call 703.341.5767.


'/>"/>
SOURCE BNA Books
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Neurobiological Technologies Announces Filing of Certificate of Dissolution and Closing of Stock Transfer Books
2. BNA Books Announces Publication of New 2009 Cumulative Supplement to Pharmaceutical Law: Regulation of Research, Development, and Marketing
3. Elsevier Appoints Suzanne BeDell as Managing Director, Science and Technology (S&T) Books
4. Gamma Pharmaceuticals, Inc. Completes Sale and Books Revenue with National Pharmacy Chain
5. Cookstr Launches New Digital Recipe Collections Exclusively on Apples iBookstore
6. Varian Medical Systems Books $88 Million Order to Equip Proton Treatment Center
7. Elsevier Announces New 2012 Frontlist eBooks Collection on SciVerse ScienceDirect Available for Advance Purchase
8. BNA Books Announces the Publication of the 2011 Supplement to "Pharmaceutical Patent Law, Second Edition"
9. Dendreon Announces Publication of Phase 1 Study Highlighting Immunologic and Clinical Activity of Lapuleucel-T (Neuvenge(R)) in Advanced Breast Cancer Patients
10. EDAP Announces Launch of Clinical Study Combining HIFU and Chemotherapy for Localized Aggressive High Risk Prostate Cancer
11. Cephalon Announces Positive Results from a Pivotal Study of FENTORA in Opioid-tolerant Patients with Non-cancer Breakthrough Pain
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/7/2016)... -- Global Hospital Linen Supply and Management Services Market: ... supply and management services market presents a comprehensive analysis ... regional level. The study provides historic data of 2015 ... 2024 based on revenue (US$ Bn). The drivers and ... their impact on demand during the forecast period have ...
(Date:12/7/2016)... Dec. 7, 2016  Palatin Technologies, Inc. ("Palatin") ... on a previously disclosed underwritten public offering of ... acted as sole book-running manager, Roth Capital Partners ... acted as co-manager for the offering. ... in net proceeds, allowing us to continue advancing ...
(Date:12/7/2016)... 2016  Northwest Biotherapeutics (Nasdaq: NWBO ... company developing DCVax® personalized immune therapies for solid ... has not accepted the Company,s plan of remediation ... and the Company has notified Nasdaq of its ... from listing on Nasdaq.  Upon withdrawal from Nasdaq, ...
Breaking Medicine Technology:
(Date:12/7/2016)... Valley, CA (PRWEB) , ... December 07, 2016 , ... ... be used in several ways to restore a more youthful appearance to the face. ... now offer Sculptra, along with a variety of other treatments, to rejuvenate and renew ...
(Date:12/7/2016)... ... ... When it came time to blow out his candles on his 14th birthday, Estefano Reano ... Transplant team at Joe DiMaggio Children’s Hospital surprised his family with a phone call ... recipient. , “He was playing at home, when we got the phone call telling ...
(Date:12/7/2016)... ... December 07, 2016 , ... Augustine Insurance Agency, ... families and business owners in the greater Dallas metropolitan area, is announcing a ... Officer Foundation. , Established in 2009 by active police professionals in the Dallas ...
(Date:12/7/2016)... , ... OCTOBER XX, 2016 (PRWEB) (PRWEB) December ... ... another mystery. A new study entitled “Canine Filamentous Dermatitis Associated with Borrelia ... occur in dogs. The study was published in the prestigious Journal of Veterinary ...
(Date:12/7/2016)... Phoenix, Arizona (PRWEB) , ... December 07, 2016 , ... ... Juvederm®, Just in Time For The Holiday Party Season. Save Up To 33% Off ... and Laser Salon is providing the Phoenix Valley with Delightful Deals on ...
Breaking Medicine News(10 mins):