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# FDA Guidance on Drug eSubmission Requirements
- URL: https://www.fdaweb.com/fda-guidance-on-drug-esubmission-requirements/
- Published: 2017-04-07T12:00:00.000Z
- Updated: 2026-09-14T22:16:41.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138402

FDA has released a [guidance ](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM333969.pdf?ref=fdaweb.com)on “Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications.” The document describes how sponsors and applicants must organize the content that they submit to the agency electronically. It also implements the electronic submission requirements outlined in FDA’s regulations. “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 exempted from the electronic submission requirements,” the agency says.