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:2/9/2016)... report "Global Anti-Bacterial Drugs Market Assessment & Forecast: 2015 - 2019" ... North America continued to lead global anti-bacterial ... into revenues worth US$ 16,907.3 million. North ... , Latin America , Middle-East ... market is inclined towards North America and ...
(Date:2/9/2016)... BETHESDA, Md. , Feb. 9, 2016 /PRNewswire-USNewswire/ ... community for pharmaceutical professionals developing and manufacturing sterile ... Global Sterile Manufacturing Regulatory Guidance Comparison – With ... regulatory guidance documents issued by the U.S. FDA, ... World Health Organization. --> ...
(Date:2/8/2016)... Feb.8, 2016 Alzheimer Diagnostic Tests - ... Medical Devices sector report , "Alzheimer Diagnostic ... an overview of Alzheimer Diagnostic Tests currently in ... on the pipeline products with comparative analysis of ... report reviews major players involved in the pipeline ...
Breaking Medicine Technology:
(Date:2/8/2016)... ... February 08, 2016 , ... Delta Dental of California and its ... cancer. , Gary D. Radine, who recently retired as president and CEO of Delta ... 2015 CEO of the Year , helped lead the effort to raise funds ...
(Date:2/8/2016)... ... February 08, 2016 , ... Eating ... a significant number of women and men with eating disorders report a history ... best predicts the development of an eating disorder. , At the 2016 ...
(Date:2/8/2016)... ... February 08, 2016 , ... GrassrootsHealth published data from ... type 2 diabetes in the GrassrootsHealth cohort with substantially higher vitamin D levels ... in public health,” states Carole Baggerly, Director of GrassrootsHealth, “the safety and ...
(Date:2/8/2016)... ... February 08, 2016 , ... Joshua Rosenthal, PhD, Chief Scientific ... can use newly released government data on populations and physicians to better calculate ... capture the value they create to succeed in new economic models for value ...
(Date:2/8/2016)... , ... February 08, 2016 , ... ... only four states in the U.S. require dental technicians to be certified or ... the dental industry, NADL created the “What’s In Your Mouth?” campaign to inform ...
Breaking Medicine News(10 mins):