The following guideline can be ordered through the address listed in the "Source/Publisher"-category. In cases in which you can order through the Internet we have established a hyperlink.
FDA Guidance for Industry: M8 Electronic Common Technical Document (eCTD) v4.0 - Draft Implementation Guide v2.0
Origin/Publisher:
FDA, http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM443847.pdf
Content:
This is a technical document that provides instructions on how to implement the eCTD v4.0 specification
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