How Do We Communicate? The Ways and Means and Getting Better
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*Stephen Wilson, U.S. Food and Drug Administration 

Keywords: communication

To improve what we do in reviewing new drugs and biologics, we need to better understand each other. We meet, we read, we talk, we analyze, we evaluate, we question, we learn and we decide. The ways and means are there -- from submissions to reviews, from meetings to guidance, from standards to statistical innovations, from templates to GRMPs, and from SAPs to SPAs. This presentation will describe the regulatory communications landscape, focusing on best practices for review and sponsor statisticians.