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Both the Prescription Drug User Fee Act (PDUFA) and the Medical Device User Fee Act (MDUFA) have worked to advance public health, safeguard patient safety, and give patients greater access to life-saving new medicines and medical devices. However, in recent years, the original successes of PDUFA/MDUFA may have slipped, partly due to additional responsibilities placed on the FDA. Both laws are critical to patients receiving timely access to breakthrough medicines and technologies, and to maintaining the United States as the global leader in life sciences innovation.

Please join us for two panel discussions of the critical issues facing Congress as it prepares to reauthorize PDUFA and MDUFA in 2012. Ralph Hall of B&D Consulting will join other policy specialists, industry leaders and congressional staff members in leading one of the discussions. The panels will address:

• How the PDUFA/MDUFA frameworks are structured and have evolved over time
• The FDA's perspective on the value and role of user fees at the agency
• Key components of the current PDUFA technical agreement with industry
• Stakeholder concerns regarding risk/benefit balancing for new products
• Opportunities for improving regulatory science and procedures for evaluating new medicines and medical devices