FDA releases draft Module 1 specification v2.0 - not for implementation

The U.S. Food and Drug Administration (FDA) has published the draft "eCTD Backbone Files Specification for Module 1 Version 2.0" together with the updated "Comprehensive Table of Contents Headings and Hierarchy Version 2". 

In addition to these documents, draft US Regional DTD (version 3.0), US Regional style sheets and attribute lists have been released.

Please note that all these documents are current draft versions for consideration only and must not be used for implementation!

There are numerous and very substantial changes incorporated into the draft Module 1 specification version 2.0. The changes made are consistent with eCTD v4, to be implemented using the Regulated Product Submission (RPS) exchange standard. Changes are summarized in appendix 2 of the specification document.

All documents and files are available from the FDA website (see link at the bottom of this article).

[Source: FDA website]

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