FDA

Dataset-JSON as Alternative Transport Format for Regulatory Submissions

Our Impact in the Evolving Data Landscape

Data sources and the volume of data available for driving discovery and informing decisions have substantially increased over time. This increase has resulted in an evolving data and regulatory landscape ripe for the expertise of statisticians and …

R pilot submissions to FDA

On Nov 22nd, 2021, the R Consortium R Submissions Working Group successfully submitted an R-based test submission package through the FDA eCTD gateway. The submission package has been received by the FDA staff who were able to reproduce the numerical …

Submitting Data to CDER: What Comes Next?

abstract to follow

SENDing Toxicology Study Data Analysis into the 21st Century with a New R Package: sendigR.

The CDISC-SEND data standard has created new opportunities for collaborative development of open-source software solutions to facilitate cross-study analyses of toxicology study data. A public private partnership between BioCelerate and FDA/CDER was …

Challenges in an Evolving Regulatory Landscape: How Statisticians Can Contribute

With recent technological advances and availability of new data sources, we are experiencing exciting changes to the human medical product regulatory landscape. While these new areas have created challenges, they also present opportunities. This …

geoMapr: A Shiny Application for Enriched Analysis of Drug Utilization Data

The crisis of opioid abuse and overdose in the United States has involved unprecedented levels of opioid prescriptions and opioid-related mortality. Greater understanding of current trends in prescription opioid utilization may help prevent new cases …

Simulations, and Complex Innovative Trial Designs

Interactive Visualization of Standardized CDISC-SEND-Formatted Toxicology Study Data Using R Shiny

The standardization of nonclinical study data by the Clinical Data Interchange Standards Consortium (CDISC) via the Standard for Exchange of Nonclinical Data (SEND) has created an opportunity for the collaborative development and use of open source …

The use of R for improved reproducibility of biomarker detection in liquid biopsies

Research reproducibility has been heatedly discussed in recent years. Some authors have pointed out that a large portion of published research findings is incorrect and/or irreproducible. Some state that the medical literature is as reliable as …