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

16 October 2026

In plain English

FDA's CDER and CBER announce support for Forward Compatibility for eCTD Version 4.0 for electronic drug and biologic submissions.

Read the official notice
Topic
Product safety
Regulator
FDA
Published
16 October 2026
For
Imports
Where it applies
United States
Source
FDA (Food and Drug Administration)

From the notice

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.

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