Dossier DOS-005
Dossier in NeeS format, version 5.3.5, for application ANVISA-2020-0005. The module tree below shows the 5 CTD modules with their component count and status.
Dossier ID
DOS-005
Format
NeeS
Version
5.3.5
Status
Failed
Application
Created
2022-02-07
Updated
2023-02-19
Total Modules
5
Module Tree
| Module | Title | Components | Status |
|---|---|---|---|
| 1 | Administrative Information and Prescribing Information | 12 | Pending |
| 2 | CTD Summaries | 13 | Submitted |
| 3 | Quality | 12 | Submitted |
| 4 | Nonclinical Study Reports | 15 | Completed |
| 5 | Clinical Study Reports | 14 | Completed |
Content Components (showing first 20)
| ID | Section | Title | Version | Format | Words | Status | Owner |
|---|---|---|---|---|---|---|---|
| CC-005 | 1.7.8 | Prescribing Information | 4.5 | HTML | 10,090 | Pending | Nadia Petrova |
| CC-105 | 3.1.6 | Analytical Methods | 2.5 | HTML | 9,727 | Approved | Tomoko Ikeda |
| CC-205 | 4.7.1 | Genotoxicity | 1.2 | HTML | 5,975 | Approved | James O'Brien |
| CC-305 | 5.4.1 | Study Reports – Clinical Pharmacology | 7.1 | 13,253 | Overdue | Carlos Mendez | |
| CC-405 | 5.9.7 | Study Reports – Safety | 4.9 | Word | 9,267 | Draft | Aisha Okonkwo |
| CC-505 | 4.9.7 | Toxicology Studies | 2.6 | Word | 9,578 | Active | Tomoko Ikeda |
| CC-605 | 4.4.8 | Carcinogenicity | 6.8 | Word | 13,874 | Submitted | Sarah Chen |
| CC-705 | 1.4.7 | Proposed Conditions of Approval | 7.5 | XML | 9,811 | Completed | Marcus Webb |
| CC-805 | 2.9.9 | Clinical Summary | 10.3 | 5,018 | In Progress | Dmitri Volkov | |
| CC-905 | 2.6.7 | Nonclinical Summary | 12.9 | Word | 11,048 | Pending | Carlos Mendez |
| CC-1005 | 1.2.4 | Proposed Conditions of Approval | 4.0 | HTML | 10,114 | Completed | Tomoko Ikeda |
| CC-1105 | 1.7.1 | Proposed Conditions of Approval | 6.0 | Word | 10,440 | Active | Carlos Mendez |
| CC-1205 | 1.2.1 | Cover Letter | 10.7 | HTML | 12,145 | Failed | Dmitri Volkov |
| CC-1305 | 2.5.3 | Quality Overall Summary | 8.6 | Word | 10,480 | Completed | James O'Brien |
| CC-1405 | 3.9.5 | Drug Product | 6.2 | HTML | 12,557 | Pending | Carlos Mendez |
| CC-1505 | 2.5.7 | Nonclinical Summary | 2.6 | 8,246 | Overdue | Priya Sharma | |
| CC-1605 | 2.6.6 | Nonclinical Summary | 3.2 | 13,055 | Overdue | Carlos Mendez | |
| CC-1705 | 4.6.2 | Toxicology Studies | 12.7 | XML | 2,999 | Submitted | Lieselotte van der Berg |
| CC-1805 | 1.1.5 | Application Form | 3.7 | XML | 1,894 | Submitted | Lieselotte van der Berg |
| CC-1905 | 2.9.3 | Quality Overall Summary | 7.1 | Word | 13,493 | Pending | Tomoko Ikeda |
Showing 20 of 20 components