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thank you elias and good morning everyone my name is john concado and iamp;#39;ll start this session the objectives of our combined presentations are to introduce the concept of real world evidence and discuss related fda initiatives describe examples of rwe used in regulatory decision making and consider the future direction of rwe involving fda my presentation will focus on rwe from the perspective of the center for drugs and also the center for biologics iamp;#39;ll first mention that evidence can be perceived in various ways as shown in this cartoon the title is todayamp;#39;s random medical news from the new england journal of panic inducing gobbledygook and it says ing to a report released today spin the wheel coffee can cause depression in twins for real world evidence and with the focus on drugs and biologics as mentioned my goals are to provide an overview of fdaamp;#39;s real world evidence program describe the concepts of fit for use data and adequate study design and al
