FDA releases final version 2.0 of the US eCTD Module 1 specification

The U.S. Food and Drug Administration (FDA) has released the final version 2.0 of the regional US eCTD Module 1 specification files.

The Module 1 eCTD specification files have been released earlier as draft versions which were open for comments from stakeholders. Version 2 incorporates several major updates to module 1 of the eCTD to "reflect regulatory changes, to provide clarification of business rules for submission processing and review, to refine the characterization of promotional marketing and advertising material, and to facilitate automated processing" (quotation from FDA website).

Important Note from the FDA: The final version 2 specification documents are released for planning and preparation purposes only. They are not to be used yet for implementation. FDA will provide notice of its ability to receive submissions based on these specifications 30 days in advance of implementation currently scheduled for 2013

All files are available from the FDA eCTD Module 1 website.

[Source: FDA]

Related News:

 FDA releases draft Module 1 specification v2.0 - not for implementation - 27.10.2011 22:17

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