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FEDERAL REGISTER · NOTICEOctober 16, 2026NOTICE — NO LEGAL EFFECT

Electronic Common Technical Document (eCTD); Data Standards; Supporting Forward Compatibility for eCTD 4.0

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Document details are published in the U.S. Federal Register; SPEQ surfaces them for reference and is not affiliated with or endorsed by the FDA or the Office of the Federal Register. The authoritative text is on federalregister.gov.

STATUSNOTICE — NO LEGAL EFFECT
EFFECTIVE—
COMMENTS CLOSE—
APPLIES TO · SPEQ TAGDrugBiologics
Document type
Notice
Agency
Health and Human Services Department
Published
October 16, 2026
Document number
2026-21197
Docket
FDA-2018-D-1216
ABSTRACT

The Food and Drug Administration's (FDA or Agency) Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research are announcing support for Forward Compatibility for Electronic Common Technical Document (eCTD) Version 4.0 (v4.0)-based electronic submissions.

Abstract as published in the Federal Register.

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