Zdrowie i gospodarka · 13.02.2013
Documents To Support Submission of an Electronic Common Technical Document; Availability
The Food and Drug Administration (FDA) is announcing the availability of the following revised final versions of documents that support making regulatory submissions in electronic format using the electronic Common Technical Document (eCTD) specifications: "The eCTD Backbone Files Specification for Module 1, version 2.1" (which includes the U.S. regional document type definition, version 3.1), and "Comprehensive Table of Contents Headings and Hierarchy, version 2.1." Technical files that support these documents are also available on the Agency Web site. A complete summary of the revisions made is included in the updated documents. FDA estimates it will be able to receive submissions utilizing Module 1 Specifications 2.1 by September 2013 and will give 30 days advanced notice to industry.