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# Study Data Technical Conformance Guide
- URL: https://www.fdaweb.com/study-data-technical-conformance-guide/
- Published: 2023-05-11T12:00:00.000Z
- Updated: 2026-09-14T18:31:09.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154432

FDA has published a *Study Data Technical Conformance Guide* incorporating a prior guidance, *Providing Regulatory Submission in Electronic Format — Standardized Study Data*. The [guide](https://www.fda.gov/media/153632/download?ref=fdaweb.com) provides specifications, recommendations, and general considerations on how to submit standardized study data using FDA-supported data standards located in the FDA Data Standards Catalog.

The guide provides technical recommendations for sponsors for the submission of animal and human study data and related information in a standardized electronic format in INDs. NDAs, ANDAs, and BLAs. FDA says it is intended to complement and promote interactions between sponsors and agency review divisions. But it is not intended to replace the need for sponsors to communicate directly with review divisions regarding implementation approaches or issues relating to data standards.