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# Guide on Drug Standardized Study Date eSubmissions
- URL: https://www.fdaweb.com/guide-on-drug-standardized-study-date-esubmissions/
- Published: 2020-10-30T12:00:00.000Z
- Updated: 2026-09-14T16:34:41.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5147991

FDA has released a revised guidance on *Providing Regulatory Submissions in Electronic Format — Standardized Study Data*. The document and technical specifications documents it incorporates by reference describe the requirements for an electronic submission of standardized clinical and nonclinical study data.

The guidance revises the types of submissions that are exempted from the electronic submission requirements for standardized study data by updating the term “noncommercial products” to “noncommercial IND.” It was also updated to clarify the information FDA relies on for assessing compliance with study data requirements.