Dossier DOS-030

Dossier in eCTD format, version 7.5.3, for application MFDS-2020-0030. The module tree below shows the 5 CTD modules with their component count and status.

Dossier ID
DOS-030
Format
eCTD
Version
7.5.3
Status
Failed
Application
MFDS-2020-0030
Created
2022-05-15
Updated
2023-07-20
Total Modules
5
Module Tree
ModuleTitleComponentsStatus
1Administrative Information and Prescribing Information12Completed
2CTD Summaries4Overdue
3Quality6Blocked
4Nonclinical Study Reports15In Progress
5Clinical Study Reports9Blocked
Content Components (showing first 20)
IDSectionTitleVersionFormatWordsStatusOwner
CC-0301.9.9Application Form12.1HTML1,161ActiveNadia Petrova
CC-1303.8.9Appendices1.1Word4,764ActiveAisha Okonkwo
CC-2303.4.7Manufacturing Process3.4HTML3,398CompletedLieselotte van der Berg
CC-3301.6.5Cover Letter12.4XML10,916In ProgressSarah Chen
CC-4302.7.1Clinical Summary6.9Word2,551ApprovedCarlos Mendez
CC-5301.3.7Application Form4.1XML5,659FailedSarah Chen
CC-6302.6.7Clinical Summary10.3XML4,690DraftPriya Sharma
CC-7304.4.5Genotoxicity4.2HTML6,830CompletedDmitri Volkov
CC-8301.7.4Application Form7.7PDF8,294OverdueMarcus Webb
CC-9302.3.8Clinical Summary3.3HTML7,402OverdueAisha Okonkwo
CC-10301.3.8Application Form5.4XML9,095SubmittedLieselotte van der Berg
CC-11305.1.8Study Reports – Safety8.1HTML9,394CompletedNadia Petrova
CC-12302.3.1Nonclinical Overview4.7HTML14,742DraftCarlos Mendez
CC-13305.4.8Study Reports – Safety2.9Word8,235ActiveJames O'Brien
CC-14301.6.2Application Form9.9HTML12,875ActiveMarcus Webb
CC-15302.9.6Quality Overall Summary9.1XML13,878ApprovedNadia Petrova
CC-16301.9.6Proposed Conditions of Approval12.7Word3,187SubmittedNadia Petrova
CC-17302.8.7Nonclinical Overview10.9Word6,845OverdueDmitri Volkov
CC-18305.9.3Integrated Summary of Safety7.5HTML6,509FailedCarlos Mendez
CC-19305.1.3Study Reports – Safety7.2PDF8,797PendingNadia Petrova