Dossier DOS-031

Dossier in NeeS format, version 5.3.8, for application TFDA-2024-0031. The module tree below shows the 5 CTD modules with their component count and status.

Dossier ID
DOS-031
Format
NeeS
Version
5.3.8
Status
Draft
Application
TFDA-2024-0031
Created
2022-09-29
Updated
2023-07-19
Total Modules
5
Module Tree
ModuleTitleComponentsStatus
1Administrative Information and Prescribing Information12Approved
2CTD Summaries15Completed
3Quality12Completed
4Nonclinical Study Reports10Draft
5Clinical Study Reports7Approved
Content Components (showing first 20)
IDSectionTitleVersionFormatWordsStatusOwner
CC-0312.3.2Quality Overall Summary11.3PDF626FailedJames O'Brien
CC-1315.1.5Integrated Summary of Efficacy7.0Word7,775BlockedPriya Sharma
CC-2315.1.2Study Reports – Safety12.2XML14,493BlockedCarlos Mendez
CC-3312.2.9Nonclinical Summary11.8XML1,628ApprovedJames O'Brien
CC-4313.9.8Analytical Methods12.6PDF6,408DraftSarah Chen
CC-5311.3.1Cover Letter7.4PDF6,577DraftJames O'Brien
CC-6314.4.8Pharmacokinetics Studies6.0PDF4,898ActiveLieselotte van der Berg
CC-7312.9.1Quality Overall Summary1.8Word6,061CompletedCarlos Mendez
CC-8313.8.7Analytical Methods12.7Word590SubmittedDmitri Volkov
CC-9311.4.4Patient Labeling5.1Word6,429OverduePriya Sharma
CC-10311.6.3Patient Labeling6.2Word6,675PendingTomoko Ikeda
CC-11311.4.6Application Form5.5Word11,693ActivePriya Sharma
CC-12313.5.6Drug Substance4.5XML9,102DraftLieselotte van der Berg
CC-13313.8.8Appendices11.4XML14,838DraftPriya Sharma
CC-14312.8.3Nonclinical Summary6.9Word4,024ActiveDmitri Volkov
CC-15313.6.1Analytical Methods10.9XML821OverdueSarah Chen
CC-16313.3.1Analytical Methods9.5PDF8,097OverdueJames O'Brien
CC-17315.2.5Integrated Summary of Efficacy4.5PDF12,986BlockedCarlos Mendez
CC-18314.4.8Toxicology Studies2.4XML13,414BlockedJames O'Brien
CC-19313.9.3Manufacturing Process9.4Word11,206SubmittedAisha Okonkwo