Using R in a regulatory environment: some FDA perspectives


The United States Food and Drug Administration (FDA) uses a variety of statistical software packages for review and research. This presentation will focus on the uses of R in the Center for Drug Evaluation and Research (CDER), including graphics for labels, Bayesian designs and analyses, simulations, machine learning, data quality and data integrity efforts, as well as interactive visualizations using R Shiny. Some of the challenges with using R will be discussed, as well as advantages of using R to collaborate with colleagues in industry and academe through Cooperative Research and Development Agreements (CRADAs), Broad Agency Agreements (BAAs), and working groups associated with professional societies (ASA, DIA, PhUSE).

Presented at 2018 Conference