The Food and Drug Administration Amendments Act of 2007 is having a major impact on the development, approval and marketing of drugs and biologics. This panel will focus on the clinical trial, labeling, and risk evaluation and mitigation strategies (REMS) provisions; how they are being implemented and impacting the broader environment beyond FDA; and how companies can minimize such risks, particularly in regard to product liability litigation.

• Inform on the current FDA implementation of clinical trials, labeling and REMS provisions
• Educate regarding current and predicted impact on product liability litigation
• Discuss steps that can be taken within the regulatory framework to mitigate these risks