The Priority Review

Regulation Brief

FDA announces support for forward compatibility of eCTD 4.0

The FDA's Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research announced support for forward compatibility of Electronic Common Technical Document (eCTD) Version 4.0. This notice informs stakeholders that submissions based on eCTD 4.0 are supported for forward compatibility.

Primary source

Federal Register notice, October 16, 2026

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

Read the source: Electronic Common Technical Document (eCTD); Data Standards; Supporting Forward Compatibility for eCTD 4.0 federalregister.gov

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