eCTD submission

US FDA will be accepting eCTD submission with U.S. Regional DTD V3.3 only from 1st March 2022

The US Food and Drug Administration’s (FDA or Agency) has announced the date that they will no longer support electronic submissions using the Electronic Common Technical Document (eCTD) Backbone Files Specification for Module 1 Version 1.3, Comprehensive Table of Contents Headings and Hierarchy Version 1.2.2, U.S. Regional Document Type Definition (DTD) Version 2.01 after March 1, […]

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