FDA Issued New eCTD Technical Conformance Guide

The guide appears to incorporate lessons learned, issues previously contained only in the eCTD validation criteria as well as the ICH eCTD Q&A document.

FDA intends to issue an initial Federal Register notice announcing its availability and seeking public comment on its contents.

“FDA Guide”:http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/UCM465411.pdf

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