Development of R-shiny application(s) an open-source tool and package to enable the generation of identified interactive plots for clinical review and direct inclusion in submission packages for submissions to regulatory agencies. Initial The initial scope is to develop tools a package to generate interactive forest and volcano plots for adverse events and FDA Medical Queries (FMQs) analysis outputs for inclusion in submission submissions to the FDA. This work is in conjunction with a collaboration among the American Statistical Association (ASA), PHUSE and the FDA. |
