Using R in a regulatory environment: FDA experiences.
The Food and Drug Administration (FDA) regulates products which account for approximately one fourth of consumer spending in the United States of America, and has global impact, particularly for medical products. This talk will discuss the Statistical Software Clarifying Statement (http://www.fda.gov/ForIndustry/DataStandards/StudyDataStandards/ucm445917.htm), which corrects the misconception that FDA requires the use of proprietary software for FDA submissions. Next, we will describe several use cases for R at FDA, including review work, research, and collaborations with industry, academe and other government agencies. We describe advantages, challenges and opportunities of using R in a regulatory setting. Finally, we close with a brief demonstration of a Shiny openFDA application for the FDA Adverse Event Reporting System (FAERS) available at https://openfda.shinyapps.io/LRTest/.