Dossier DOS-067
Dossier in NeeS format, version 3.3.1, for application TGA-2023-0067. The module tree below shows the 5 CTD modules with their component count and status.
Dossier ID
DOS-067
Format
NeeS
Version
3.3.1
Status
In Progress
Application
Created
2022-08-28
Updated
2023-10-19
Total Modules
5
Module Tree
| Module | Title | Components | Status |
|---|---|---|---|
| 1 | Administrative Information and Prescribing Information | 7 | Completed |
| 2 | CTD Summaries | 6 | Approved |
| 3 | Quality | 9 | Overdue |
| 4 | Nonclinical Study Reports | 13 | Approved |
| 5 | Clinical Study Reports | 3 | Blocked |
Content Components (showing first 20)
| ID | Section | Title | Version | Format | Words | Status | Owner |
|---|---|---|---|---|---|---|---|
| CC-067 | 5.2.7 | Integrated Summary of Efficacy | 3.5 | HTML | 715 | Pending | Tomoko Ikeda |
| CC-167 | 3.6.5 | Drug Product | 7.8 | XML | 6,262 | Submitted | Sarah Chen |
| CC-267 | 1.5.3 | Prescribing Information | 3.6 | XML | 12,777 | Completed | Dmitri Volkov |
| CC-367 | 2.9.6 | Clinical Overview | 10.6 | XML | 12,494 | In Progress | Sarah Chen |
| CC-467 | 1.9.8 | Patient Labeling | 2.7 | Word | 12,401 | Submitted | Lieselotte van der Berg |
| CC-567 | 1.4.2 | Application Form | 5.2 | Word | 7,784 | Draft | Carlos Mendez |
| CC-667 | 2.8.2 | Clinical Overview | 5.1 | XML | 1,821 | Submitted | Carlos Mendez |
| CC-767 | 1.8.1 | Cover Letter | 8.1 | HTML | 10,600 | Active | Carlos Mendez |
| CC-867 | 1.4.4 | Prescribing Information | 5.5 | Word | 10,609 | Submitted | Aisha Okonkwo |
| CC-967 | 1.7.1 | Proposed Conditions of Approval | 11.9 | 5,604 | Failed | Dmitri Volkov | |
| CC-1067 | 4.1.3 | Carcinogenicity | 11.8 | Word | 6,315 | Failed | Sarah Chen |
| CC-1167 | 4.5.9 | Pharmacology Studies | 7.0 | XML | 9,475 | Draft | Sarah Chen |
| CC-1267 | 4.4.3 | Carcinogenicity | 11.2 | Word | 5,682 | Blocked | Priya Sharma |
| CC-1367 | 1.4.1 | Application Form | 6.2 | XML | 7,227 | Overdue | Tomoko Ikeda |
| CC-1467 | 4.7.5 | Pharmacokinetics Studies | 5.1 | 7,297 | Submitted | Nadia Petrova | |
| CC-1567 | 2.9.2 | Nonclinical Summary | 3.9 | XML | 1,503 | Blocked | Aisha Okonkwo |
| CC-1667 | 1.4.3 | Proposed Conditions of Approval | 4.4 | Word | 13,288 | Failed | Tomoko Ikeda |
| CC-1767 | 4.3.2 | Carcinogenicity | 10.4 | Word | 9,672 | Active | Tomoko Ikeda |
| CC-1867 | 1.3.9 | Cover Letter | 10.5 | Word | 1,532 | In Progress | Tomoko Ikeda |
| CC-1967 | 4.2.7 | Pharmacokinetics Studies | 9.4 | Word | 5,869 | In Progress | Carlos Mendez |
Showing 20 of 20 components