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Zdrowie i gospodarka · 16.10.2020

Electronic Common Technical Document; Data Standards; Support Ends for Electronic Common Technical Document Module 1 U.S. Regional Document Type Definition Version 2.01 and Requirement Begins for Electronic Common Technical Document Module 1 U.S. Regional Document Type Definition Version 3.3

The Food and Drug Administration's (FDA or Agency) Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research are announcing the date that FDA 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, and U.S. Regional Stylesheet Version 1.1, and will require electronic submissions to be submitted using eCTD Module 1 U.S. Regional DTD Version 3.3. The Agency will update the eCTD Submission Standards document to reflect these changes.

Source: Federal Register — Food and Drug AdministrationOpen original release →