Standardized study data describe the observations from a clinical trial, and standardized analysis (Analysis Data Model [ADaM]) data are created to use the information from a study — both are critical elements in the submission and review of regulated drugs and biologics. We need to describe, discuss and solve the problems associated with many important analysis data issues/opportunities: Therapeutic area analysis data standards, refuse-to-file considerations, and the EMA's unprecedented call for the submission and secondary use of "raw data." This session will provide an overview of important issues associated with the development, application, submission and review of analysis data.