Dossier DOS-003

Dossier in CTD format, version 6.5.3, for application PMDA-2022-0003. The module tree below shows the 5 CTD modules with their component count and status.

Dossier ID
DOS-003
Format
CTD
Version
6.5.3
Status
Pending
Application
PMDA-2022-0003
Created
2022-02-21
Updated
2024-06-11
Total Modules
5
Module Tree
ModuleTitleComponentsStatus
1Administrative Information and Prescribing Information3Overdue
2CTD Summaries12Completed
3Quality12Submitted
4Nonclinical Study Reports6Submitted
5Clinical Study Reports5Overdue
Content Components (showing first 20)
IDSectionTitleVersionFormatWordsStatusOwner
CC-0033.1.1Analytical Methods8.6XML2,604ActiveCarlos Mendez
CC-1031.7.4Patient Labeling10.2PDF10,160ActiveSarah Chen
CC-2035.5.9Study Reports – Clinical Pharmacology11.1XML8,715DraftDmitri Volkov
CC-3032.3.7Clinical Overview1.9HTML14,321PendingSarah Chen
CC-4035.9.7Study Reports – Safety8.5XML6,557PendingDmitri Volkov
CC-5032.7.6Nonclinical Overview7.2XML6,559PendingAisha Okonkwo
CC-6032.1.2Clinical Summary1.7Word2,392In ProgressDmitri Volkov
CC-7032.4.3Quality Overall Summary8.7XML3,190PendingPriya Sharma
CC-8031.7.7Patient Labeling7.4Word9,865ActiveJames O'Brien
CC-9032.2.1Nonclinical Overview7.0HTML13,937SubmittedDmitri Volkov
CC-10031.7.9Application Form10.7PDF11,003SubmittedPriya Sharma
CC-11034.3.7Toxicology Studies8.8Word8,297ApprovedCarlos Mendez
CC-12035.8.6Integrated Summary of Safety3.6XML4,948In ProgressTomoko Ikeda
CC-13034.3.2Pharmacology Studies9.3HTML14,863In ProgressAisha Okonkwo
CC-14033.5.9Stability Data7.6Word9,408DraftLieselotte van der Berg
CC-15034.9.4Genotoxicity1.8Word13,739In ProgressJames O'Brien
CC-16035.6.5Study Reports – Efficacy12.4Word6,863ActiveSarah Chen
CC-17033.8.7Drug Product12.5Word3,291PendingAisha Okonkwo
CC-18035.7.8Study Reports – Efficacy8.3HTML9,686BlockedNadia Petrova
CC-19034.1.2Toxicology Studies4.5Word4,783In ProgressLieselotte van der Berg