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Pharmaceutical Law

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

  • Publisher: American Bar Association
  • ISBN: 9781570189951
  • Published In: December 2011
  • Format: Paperback , 899 pages
  • Jurisdiction: U.S. ? Disclaimer:
    Countri(es) stated herein are used as reference only
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  • Description 
  • 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)

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