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Feb 25, 2022 — This technical specifications document represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic.eCTD Technical Conformance Guide - FDAfda.gov › media › downloadfda.gov › media › downloadPDF Feb 24, 2020 — The eCTD v4.0 Technical Conformance Guide will provide specifications, recommendations, and general considerations on how to submit eCTD the non-clinical Study Data Reviewer's Guide (“nsdrg.pdf”) to reflect lower case instead of upper case. eCTD requires lower case file names. March 2017.eCTD. TECHNICAL CONFORMANCE GUIDE. Technical Specifications Document The eCTD Guidance implements the electronic submission requirements of section. Oct 6, 2015 — The eCTD Technical Conformance Guide supplements the guidance for industry entitled ``Providing Regulatory Submissions in Electronic May 29, 2020 — eCTD TECHNICAL CONFORMANCE GUIDE. Download the Guidance Document. Final. Issued by: Food and Drug Administration (FDA). Aug 23, 2021 — To help sponsors understand how the FDA uses the eCTD technical validation rules to verify conformance, the agency developed the technical You should not include the eCTD section number in the leaf title. Page 8. 6. Type of Submission. Leaf title subheadings Leaf title. REMS Assessment. You should not include the eCTD section number in the leaf title. Page 8. 6. Type of Submission. Leaf title subheadings Leaf title. REMS Assessment.