FDA Guidance for Industry: M2 eCTD: Electronic Common Technical Document Specification

Titel:
FDA Guidance for Industry: M2 eCTD: Electronic Common Technical Document Specification
Internet:

https://www.gmp-navigator.com/files/guidemgr/5415fnl[2].pdf

Herkunft/Verlag:

FDA, http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm073240.pdf

Inhalt:
Die ICH M4 Expert Working Group (EWG) definiert den Common Technical Document (CTD).

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