Dossier DOS-007

Dossier in eCTD format, version 7.6.1, for application TGA-2023-0007. The module tree below shows the 5 CTD modules with their component count and status.

Dossier ID
DOS-007
Format
eCTD
Version
7.6.1
Status
Draft
Application
TGA-2023-0007
Created
2023-01-28
Updated
2023-11-07
Total Modules
5
Module Tree
ModuleTitleComponentsStatus
1Administrative Information and Prescribing Information12Overdue
2CTD Summaries11Failed
3Quality4Active
4Nonclinical Study Reports7Completed
5Clinical Study Reports5In Progress
Content Components (showing first 20)
IDSectionTitleVersionFormatWordsStatusOwner
CC-0074.7.1Pharmacokinetics Studies11.2HTML12,357PendingSarah Chen
CC-1074.2.8Toxicology Studies3.1HTML12,911ApprovedDmitri Volkov
CC-2074.3.5Genotoxicity9.6PDF5,697CompletedAisha Okonkwo
CC-3072.7.4Clinical Summary11.1HTML13,697OverduePriya Sharma
CC-4075.7.1Study Reports – Safety5.7Word9,768FailedLieselotte van der Berg
CC-5074.6.1Pharmacokinetics Studies9.0HTML8,989CompletedPriya Sharma
CC-6075.7.9Study Reports – Clinical Pharmacology12.6HTML2,426In ProgressDmitri Volkov
CC-7074.1.4Toxicology Studies3.2PDF7,259FailedTomoko Ikeda
CC-8075.1.3Study Reports – Efficacy9.1XML4,251ActiveSarah Chen
CC-9074.2.8Genotoxicity5.5PDF5,519SubmittedTomoko Ikeda
CC-10072.4.3Clinical Overview6.0PDF5,511BlockedLieselotte van der Berg
CC-11072.2.6Clinical Overview9.8XML5,147SubmittedNadia Petrova
CC-12073.3.6Appendices3.8PDF6,521FailedPriya Sharma
CC-13073.6.6Analytical Methods2.1HTML11,332CompletedDmitri Volkov
CC-14075.7.8Study Reports – Clinical Pharmacology2.9Word3,863BlockedJames O'Brien
CC-15075.3.4Integrated Summary of Safety3.3XML1,281PendingAisha Okonkwo
CC-16071.4.6Application Form8.6Word13,306ApprovedNadia Petrova
CC-17075.1.3Study Reports – Efficacy4.0XML7,953SubmittedLieselotte van der Berg
CC-18071.9.8Cover Letter9.0Word13,263DraftJames O'Brien
CC-19075.6.3Study Reports – Safety7.6XML9,108BlockedJames O'Brien