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).
To find more information please use the below mentioned weblink
http://www.exalon.com/ectd-news/news-details/article/fda-releases-final-version-20-of-the-us-ectd-module-1-specification.html
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).
To find more information please use the below mentioned weblink
http://www.exalon.com/ectd-news/news-details/article/fda-releases-final-version-20-of-the-us-ectd-module-1-specification.html
No comments:
Post a Comment