In October 2007, Congress passed new legislation giving the FDA a number of new powers, the most important of which is the authority to require companies to establish risk management programs called REMS (Risk Evaluation and Mitigation Strategies). REMS are widely expected to have an enormous impact on biopharmaceutical development and marketing. This panel will review key aspects of the legislation, the industry's experience to date and new opportunities and challenges ahead.

• Explain the main provisions of FDAA as they relate to drug safety
• Provide case studies of companies which have established risk management programs
• Highlight the potential impact of REMS on drug development and business development