Guidance on Submitting Standardized Study Data

FDA issued guidance in October 2020 describing the requirements for electronically submitting standardized clinical and nonclinical study data under section 745A(a) of the Federal Food, Drug, and Cosmetic Act for new drug applications, abbreviated new drug applications, biologics license applications, and investigational new drug applications to the Center for Drug Evaluation and Research or the Center for Biologics Evaluation and Research. “Submissions that are not submitted electronically and electronic submissions that are not in a format that FDA can process, review, and archive will not be filed or received, unless exempt from the electronic submission requirements or if FDA has granted a waiver,” the guidance states.

The guidance discusses the requirements for electronic submission of study data including exchange format standards, study data standards, and controlled terminology standards. It also discusses the agency’s policy on waivers of electronic submission requirements.