FDA’s eCTDv4.0 Technical Conformance Guide: Open for Comments
The FDA has finalized guidance documents on eCTD submission format for eCTDv4.0 Technical Conformance Guidance and the FDA eCTDv4.0 Module 1 Implementation Package.
The FDA also requesting for public comment for two eCTD technical documents, the eCTD v4.0 Technical Conformance Guidance and the FDA eCTD v4.0 Module 1 Implementation Package.
The eCTD v4.0 Technical Conformance Guide will provide specifications, recommendations, and general considerations on how to submit eCTD v4.0-based electronic submissions to the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER) using the International Council for Harmonisation eCTD v4.0 Implementation Package and the FDA eCTD v4.0 Module 1 Implementation Package.
The FDA is seeking comment on the eCTD v4.0 Technical Conformance Guide and the FDA eCTD v4.0 Module 1 Implementation Package for the accuracy, suitability, and appropriateness of these specifications for the submission of eCTD v4.0 submissions. These versions of the documents are not for implementation.
Unless and until v4.0 is finalized the agency will only accept eCTD v3.2.2 submissions.
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