PrecisionFDA Request for Information

The Food and Drug Administration (FDA) plays an integral role in precision medicine initiatives, which foresees the day when an individual’s medical care will be tailored in part based on their unique characteristics and genetic make-up. To this end, the FDA is developing the tools, standards, and approaches needed to ensure that genomic tests provide reliable and accurate genetic results. This effort is one part of the FDA's commitment to leverage external resources and expertise to advance regulatory science, the science that is essential for product development and evaluation and which underpins the FDA’s regulatory decision-making. PrecisionFDA is a FISMA-authorized secure cloud-based portal, analysis platform and data repository which enables collaboration and sharing of large datasets by reviewers, bioinformaticians, researchers, and data scientists from industry, academia, government, and other partners. Specifically, precisionFDA enables collaboration between FDA researchers and reviewers, as well as external collaborators and sponsors to come together to foster and develop the regulatory science to support regulation of multi-omics and Real-World Data (RWD) informatics in drugs and devices. This includes genomics, transcriptomics, proteomics, metabolomics, imaging, and electronic health record data from healthcare partners. This integration of multi-omics and RWD is helping to deliver safe and effective treatments precision-tailored to individuals and groups, thus the name precisionFDA. This contract includes the maintenance of the current operational system, as well as enhancements to that system. The diagram below visually conveys the current scope and uses of the precisionFDA program.