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# FDA Wants eSubmissions to Conform to Data Standards
- URL: https://www.fdaweb.com/fda-wants-esubmissions-to-conform-to-data-standards/
- Published: 2016-11-14T12:00:00.000Z
- Updated: 2026-09-14T21:47:09.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5137330

FDA says it has amended its electronic submission “[Technical Rejection Criteria for Study Data](http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/UCM523539.pdf?ref=fdaweb.com)” to require study data standards in conformance to required standards specified in the FDA Data Standards Catalog for clinical and nonclinical studies that start after 12/17\. Technical rejection criteria are being added to the existing eCTD validation criteria to enforce the deadline. FDA is giving industry 30 days’ notice on the eCTD Web site prior to the criteria becoming effective. The agency says it may “refuse to file” NDAs and BLAs, or refuse to receive ANDAs for electronic submissions that don’t have study data in conformance to the required standards.