Online Program

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Thursday, September 13
Thu, Sep 13, 11:45 AM - 1:00 PM
Various Rooms
Roundtable Discussions

TL41: Using R Shiny and Markdown in a Regulated and Regulatory Environment: Industry and FDA Experiences (300591)

*Xiao Ni, Novartis 

Keywords: R, Shiny, Markdown, Reproducible research, Visualizations, Dynamic displays

Shiny ( is a web application framework created by RStudio, Inc. and licensed as a free open source R package, that is used to turn analyses created in R into interactive web applications without requiring web programming skills. Shiny Server Pro allows analysts to share and publish their Shiny applications, authenticate user access and scale and manage R processes. R Markdown provides an authoring framework for making dynamic and reproducible documents in various format such as HTML, PDF, and MS Word documents.

Shiny and R Markdown have been widely used in various industries with examples found in the galleries on The interactive user experience in a modern web framework makes Shiny a desirable tool for gaining insight into the complex data. The versatility, reproducibility and literate programming environment make R Markdown a nice reporting tool. The FDA's Office of Health Informatics (OHI) has developed several Shiny applications and hosted them on the RStudio's public servers, as part of the openFDA initiative.

This lunch round table intends to provide a venue for industry and FDA statisticians to discuss the use cases, as well as the potential use of Shiny/Rmarkdown for regulatory submission in the context of the 21 CFR Part 11 guidance.

This session presents a novel yet important topic that warrants discussion and collaboration between industry and FDA statisticians.