21.04.2015

FDA revises example submission code using the new Module 1 version 2.3

Flag of USA

The FDA has released some some revised information related to the forthcoming new Module 1 version 2.3 which is targeted to come into effect in Q3 2015. The revision concerns the Example Submissions using the eCTD Backbone Files Specification for Module 1 which has been updated to version 1.4, dated 01-Apr-2015.

The "Example Submissions" document contains XML code of the us-regional.xml file of some example submissions that are based on the current DTD version 3.3. Example 27 contained in the document shows an amendment to 2 Efficacy supplements in the same application.

In the new revised version 2.3, the reference to Form FDA 356h from the 2nd application in the application set has been removed as for grouped submissions to the same application, the form should only be referenced once, in the application where application-containing-files = “True”.

The amended <application-set>section has also been provided as separate Addendum 2 to the eCTD Backbone Files Specification for Module 1 Version 2.3

[Source: FDA]

 

 

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