Steps to Comply with the FDA’s Binding Guidance on Electronic Study Data Submissions

On December 18th 2014, the FDA issued binding guidance regarding electronic submissions of nonclinical study data. This means that beginning in 2017, any organization making IND, NDA or BLA submissions of nonclinical studies will need to plan for, and be ready, to submit their studies in the required standardized digital format that is directly consumable by the FDA’s NIMS review and analysis tool.

The links provided at the end of this white paper point to useful reference documents. These include the FDA guidance and technical specifications, as well as Agency presentations on the tools and processes they have in place to modernize regulatory reviews through the use of standardized data. The FDA uses their NIMS system to perform data fitness checks on submitted standardized studies and to present them to the medical reviewers.