FDA Guidance for Industry: M2 eCTD: Electronic Common Technical Document Specification
Title:
FDA Guidance for Industry: M2 eCTD: Electronic
Common Technical Document
Specification
Origin/Publisher:
FDA, http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm073240.pdf
Content:
The ICH M4 Expert Working Group (EWG) has defined the Common Technical Document (CTD).