Dossier DOS-066

Dossier in eCTD format, version 1.5.8, for application HC-2024-0066. The module tree below shows the 5 CTD modules with their component count and status.

Dossier ID
DOS-066
Format
eCTD
Version
1.5.8
Status
Failed
Application
HC-2024-0066
Created
2022-05-09
Updated
2024-04-02
Total Modules
5
Module Tree
ModuleTitleComponentsStatus
1Administrative Information and Prescribing Information8Failed
2CTD Summaries9Approved
3Quality5Completed
4Nonclinical Study Reports11Draft
5Clinical Study Reports5Approved
Content Components (showing first 20)
IDSectionTitleVersionFormatWordsStatusOwner
CC-0664.4.3Pharmacology Studies9.1XML10,586In ProgressAisha Okonkwo
CC-1665.9.1Study Reports – Safety1.9XML12,055OverdueJames O'Brien
CC-2662.3.7Nonclinical Summary6.3PDF12,100FailedDmitri Volkov
CC-3662.8.9Clinical Summary7.7HTML12,569SubmittedAisha Okonkwo
CC-4664.3.9Genotoxicity9.7Word8,498In ProgressNadia Petrova
CC-5664.7.1Carcinogenicity9.6XML3,292OverdueLieselotte van der Berg
CC-6662.2.2Nonclinical Summary10.9Word12,089CompletedNadia Petrova
CC-7665.3.6Study Reports – Efficacy3.2HTML747BlockedDmitri Volkov
CC-8662.6.2Nonclinical Overview9.1HTML10,317FailedJames O'Brien
CC-9665.4.6Study Reports – Efficacy9.9XML5,183DraftTomoko Ikeda
CC-10661.9.2Proposed Conditions of Approval10.2PDF14,960PendingJames O'Brien
CC-11665.6.7Integrated Summary of Efficacy7.0Word1,950PendingSarah Chen
CC-12665.5.6Integrated Summary of Efficacy10.8HTML1,660CompletedTomoko Ikeda
CC-13665.5.7Study Reports – Safety12.2HTML4,131FailedLieselotte van der Berg
CC-14664.2.2Carcinogenicity4.9Word8,917ActiveMarcus Webb
CC-15665.6.9Integrated Summary of Efficacy11.4PDF14,157ApprovedSarah Chen
CC-16661.4.6Application Form11.2Word7,738CompletedMarcus Webb
CC-17662.6.1Quality Overall Summary5.0XML12,655FailedLieselotte van der Berg
CC-18661.3.6Cover Letter12.0PDF8,137FailedLieselotte van der Berg
CC-19661.4.5Proposed Conditions of Approval8.7Word13,300DraftJames O'Brien