eCTD:Module1 BronwynCollier,AssociateDirectorforRegulatoryAffairsOfficeofDrugEvalautionIIICenterforDrugEvaluationandResearchFDA April2005 Module1:Topics •Purpose•Impactonreviewprocess•Module1tableofcontents 2 Module1:Purpose •Archiveregionaldocuments•Applicationmanagement –Status–Business–Specialregulatory...