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# Standardized Study Data Electronic Format Guidance
- URL: https://www.fdaweb.com/standardized-study-data-electronic-format-guidance/
- Published: 2021-06-22T12:00:00.000Z
- Updated: 2026-09-14T17:04:17.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5149595

FDA has issued a guidance, *Providing Regulatory Submissions in Electronic Format—Standardized Study Data*, with the requirements for electronic submission of standardized clinical and non-clinical study data under Section 745 (a) of the Federal Food, Drug, and Cosmetic Act. The [document](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/providing-regulatory-submissions-electronic-format-standardized-study-data?ref=fdaweb.com) implements the electronic submission requirements for study data contained in NDAs, ANDAs, BLAs, and INDs for CDER and CBER by specifying the format for electronic submissions.

“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 says.