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Pharmaceutical Law Regulation of Research, Development, and Marketing, 2011 Cumulative Supplement

Name: Pharmaceutical Law
Brand: American Bar Association
SKU: 9781570189951
Price: 2300.00 HKD
Availability: OutOfStock
ISBN: 9781570189951

American Bar Association December 2011

Specifications

ISBN-13: 9781570189951
Publisher: American Bar Association
Publication: December 2011
Format: Paperback , 899 pages
Jurisdiction: U.S. ? Countri(es) for reference only

Details

The 2011 Cumulative Supplementprovides important updates on securities cases, and developments involving fraud and abuse, HIPAA, and the FDA, including:

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)