Zdrowie i gospodarka · 26.10.2011
Draft Documents To Support Submission of an Electronic Common Technical Document; Availability
The Food and Drug Administration (FDA) is announcing the availability of the following draft versions of documents that support making regulatory submissions in electronic format using the electronic Common Technical Document (eCTD) specifications entitled "The eCTD Backbone Files Specification for Module 1, version 2.0" (which includes the U.S. regional document type definition, version 3.0) and "Comprehensive Table of Contents Headings and Hierarchy, version 2.0." Supporting technical files are also being made available on the Agency Web site. These draft documents represent FDA's major updates to Module 1 of the eCTD, which contains regional information.