ISSUE: Patient preference information (PPI), elicited using established scientific methods is a promising strategy for incorporating patient input throughout the medical product lifecycle. Although much of the science behind PPI elicitation is not new, PPI’s application in a regulatory setting raises many important questions: This panel will debate on issues and questions such as: What are the appropriate applications of PPI throughout the medical product lifecycle? Is PPI informative for all disease areas, or would some areas benefit more than others? What criteria and best practices would ensure the scientific validity of PPI and support its application in a regulatory setting? OVERVIEW: The FDA has been working with stakeholders to enhance medical product benefit-risk assessment, including incorporation of patient input in regulatory decision-making. This panel calls for more collaboration among the various stakeholders to advance the science of identifying, gathering, incorporating and evaluating patient input throughout the lifecycle of medical products. Ms. Moncur will moderate the session. Dr. Noel will provide an industry perspective on how and when in the medical product lifecycle PPI are being collected and used, identify challenges, and offer some suggestions to overcome these challenges. Dr. Tegenge will provide a regulatory perspective on the potential opportunities for and challenges in applying PPI in a regulatory setting. Dr. Wilson will provide an academic perspective on improving the qualitative and quantitative methods of eliciting PPI and advancing the systematic incorporation of patient input throughout the medical product lifecycle; focusing on the issues of methods choice, sample selection, attribute selection, and study validation. Finally, workshop participants will have an opportunity to discuss and debate their viewpoints, and provide suggestions to improve the use and effectiveness of PPI.