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: 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).

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