Navigation Links
BNA Books' Announces Publication of New 2009 Cumulative Supplement to 'Pharmaceutical Law: Regulation of Research, Development, and Marketing'
Date:3/3/2010

ARLINGTON, Va., March 3 /PRNewswire-USNewswire/ -- BNA Books, a division of specialized news and information publisher BNA, announces the publication of the 2009 Cumulative Supplement to Pharmaceutical Law: Regulation of Research, Development, and Marketing. The main volume and supplement are published by BNA Books with the American Bar Association (ABA) Health Law Section.

(Logo: http://www.newscom.com/cgi-bin/prnh/20090529/DC24463LOGO)

Pharmaceutical Law: Regulation of Research, Development, and Marketing is the only resource that provides expert commentary and authoritative insights into a comprehensive range of pharmaceutical law issues. No other single volume discusses these complex issues in the detail required for transactional health care attorneys to adequately advise their 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
  • Explains and discusses the other hot risks areas—including the potential for antitrust, securities law, and other compliance violations
  • Discusses the securities law reporting obligations of drug companies for material events (such as the rejection of approval of NDAs), and how to protect clinical research subjects

The 2009 Cumulative Supplement is updated with new topics, including:

  • Kennedy-Enzi, the Enhancing Drug Safety and Innovation Act of 2006
  • The Food and Drug Administration Amendments Act of 2007
  • The FDA and preemption in the context of labeling and drug safety
  • FDA authority to regulate tobacco products
  • Changes to DTC marketing made by the Food and Drug Administration Amendments Act of 2007
  • The Health Information Technology for Economic and Clinical Health (HITECH) Act
  • HIPAA enforcement
  • Lanham Act violations
  • Class actions

This treatise also offers authoritative explanations of the complex inter-relationships between the pharmaceutical industry, health care delivery system, insurers, and regulators.

Michael E. Clark is the author of the treatise and its supplement. Mr. Clark is a member in Hamel Bowers & Clark LLP. He has a distinguished background in government and private litigation, having served as Chief of the Criminal Division of the U.S. Attorney's Office for the Southern District of Texas from 1993−1997.

BNA is a leading private publisher of news and information products for professionals in law and business. In addition to Pharmaceutical Law: Regulation of Research, Development, and Marketing with 2009 Cumulative Supplement, BNA's Book Division publishes Pharmaceutical Patent Law; Health Care Fraud and Abuse; Prosecuting and Defending Health Care Fraud; Managed Care Litigation; E-Health Business and Transactional Law; and other titles in legal specialties. For a free BNA Books catalog, call 1-800-960-1220 or send an e-mail request to books@bna.com. The BNA Books website, including an online catalog, can be found at bnabooks.com.

The 2009 Cumulative Supplement to Pharmaceutical Law: Regulation of Research, Development, and Marketing may be purchased alone (344 pp. Softcover/Order#1823-PRY9/$220.00 plus tax, shipping, and handling), or with the main volume (899 pp. Hardcover/Order #9823-PRY9/$385.00 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 bnabooks.com. Please note that discounts cannot be combined.

SOURCE BNA Books

Back to top

RELATED LINKS
http://www.bnabooks.com

'/>"/>

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. Dendreon Announces Publication of Phase 1 Study Highlighting Immunologic and Clinical Activity of Lapuleucel-T (Neuvenge(R)) in Advanced Breast Cancer Patients
3. EDAP Announces Launch of Clinical Study Combining HIFU and Chemotherapy for Localized Aggressive High Risk Prostate Cancer
4. Cephalon Announces Positive Results from a Pivotal Study of FENTORA in Opioid-tolerant Patients with Non-cancer Breakthrough Pain
5. ADVENTRX Announces Fast Track Designation Granted By the FDA For CoFactor For the Treatment of Metastatic Colorectal Cancer
6. DOV Pharmaceutical, Inc. Announces Successful Phase Ib Results for DOV 21,947
7. Phosphagenics Announces Positive Phase 1b Transdermal Insulin Clinical Trial Results
8. Xenomics Announces Implementation of its First Diagnostic Test for Acute Myeloid Leukemia Into Clinical Practice
9. Emisphere Technologies, Inc. Announces 2007 Second Quarter Financial Results
10. Amicus Therapeutics Announces Second Quarter 2007 Financial Results
11. Genta Incorporated Announces Second Quarter 2007 Financial Results and Corporate Highlights
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/4/2016)... LONDON , Feb. 4, 2016 ... Summary Global Markets Direct,s, ,Wegener Polyangiitis - ... the Wegener Polyangiitis,s therapeutic pipeline. This report ... Wegener Polyangiitis, complete with comparative analysis at various ... action (MoA), route of administration (RoA) and molecule ...
(Date:2/4/2016)... Feb. 4, 2016 Summary Breast cancer, ... and the most common cancer in women worldwide, accounting ... exceedingly prevalent. The number of women diagnosed with breast ... the number of deaths has declined due to earlier ... has been revolutionized in the past four decades, especially ...
(Date:2/4/2016)... Frontier Pharma: Chronic Obstructive Pulmonary Disease ... Chronic Obstructive Pulmonary Disease (COPD) is ... the airways and lungs. Persistent breathing difficulties and ... one of the leading causes of morbidity and ... COPD is linked to cumulative exposure to risk ...
Breaking Medicine Technology:
(Date:2/6/2016)... ... 06, 2016 , ... Research has shown that building shame ... frequency and level of relapse. , At the 2016 iaedp Symposium, ... explore the critical tasks of the recovery phase and beyond including relapse prevention ...
(Date:2/5/2016)... ... February 05, 2016 , ... Today, the Whole-Food Warrior ... that the much-anticipated feature with author Jahnavi Foster, specialist in healthy vegetarian cuisine, will ... , Each week, on his weekly Whole-Food Warrior TV show, Frank Davis highlights Whole-Food ...
(Date:2/5/2016)... Santa Rosa, CA (PRWEB) , ... February 05, ... ... are pleased to announce the addition of micro-needling services in their Napa Valley ... appearance. The founders of Plastic Surgery Associates, Dr. Canales and Dr. Furnas, are ...
(Date:2/5/2016)... ... February 05, 2016 , ... ... to funding innovative lymphoma research and serving the lymphoma community through a comprehensive ... once again host, Swirl, A Wine Tasting Event at the La Gorce Country ...
(Date:2/5/2016)... , ... February 05, 2016 , ... Regular gym users ... themselves having to wait longer to access the treadmills. It’s a predictable trend. After ... to lose weight and get in shape by joining gyms, starting new walking or ...
Breaking Medicine News(10 mins):