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

 
9781570189951: Pharmaceutical Law: Regulation of Research, Development, and Marketing, 2011 Cumulative Supplement

The 2011 Cumulative Supplement provides 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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