FDA Guidance for Industry: M4: Organization of the CTD
Title:
FDA Guidance for Industry: M4: Organization of the CTD
Origin/Publisher:
Center for Drug Evaluation and Research; Center for Biologics Evaluation and Research; Food and Drug Administration; 5600 Fishers Lane; Rockville, MD 20857; http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm ; https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM073257.pdf
Document Type:
Guidance
Content:
This guideline presents the common format for the preparation of a well-structured Common Technical Document for applications that will be submitted to regulatory authorities.