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Technology · 10/16/2026

FDA to Begin Rejecting Electronic Submissions Not Meeting New Data Standards

The FDA's Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research will start rejecting electronic submissions that do not meet the new data standards for Electronic Common Technical Document (eCTD) Version 3.2.2 and Version 4.0.

Original source language: Federal Register — Health and Human ServicesOpen original release →