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Subject: Public review comments for etmf-v1.0-csprd01: 6.1.1 OASIS eTMF Data Model Exchange Format


Comment type [editorial]

Impact [minor]

The FDA requirement for specific file formats for the Common Technical Document (eCTD) is not understood to be a requirement documented in Code of Federal Regulations Chapter 21, part 11 but simply an FDA requirement for eCTD submission.

 

It is not understood why FDA-specific regulatory requirements have been cited to the exclusion of requirements from other global regulatory agencies in this global specification / standard.

 

Eldin Rammell,

Principal Consultant, Rammell Consulting Ltd.

 



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