Pharmaceutical Law: Regulation of Research, Development, and Marketing, 2009 Cumulative Supplement

The 2009 Cumulative Supplement to Pharmaceutical Law: Regulation of Research, Development, and Marketing is updated with discussions covering several 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,Preemption of State Law-Based Personal Injury Actions Due to Pervasiveness of Federal Drug Approval Framework,An Overview of Off-Label Prescription and Promotion, Summary of 2008 Draft Guidance,The Health Information Technology for Economic and Clinical Health (HITECH) Act,The Genetic Information Nondiscrimination Act of 2008,HIPAA Enforcement,The Federal Acquisition Regulations: Mandatory Disclosure and Amplified Compliance Programs for Government Contractor,Lanham Act Violations,Class actions.