Dossier DOS-050
Dossier in NeeS format, version 5.3.4, for application MFDS-2020-0050. The module tree below shows the 5 CTD modules with their component count and status.
Dossier ID
DOS-050
Format
NeeS
Version
5.3.4
Status
Blocked
Application
Created
2022-04-10
Updated
2023-09-02
Total Modules
5
Module Tree
| Module | Title | Components | Status |
|---|---|---|---|
| 1 | Administrative Information and Prescribing Information | 11 | Approved |
| 2 | CTD Summaries | 13 | Draft |
| 3 | Quality | 14 | Submitted |
| 4 | Nonclinical Study Reports | 7 | Submitted |
| 5 | Clinical Study Reports | 12 | Submitted |
Content Components (showing first 20)
| ID | Section | Title | Version | Format | Words | Status | Owner |
|---|---|---|---|---|---|---|---|
| CC-050 | 2.4.1 | Nonclinical Overview | 6.8 | HTML | 5,210 | Failed | Nadia Petrova |
| CC-150 | 4.9.1 | Carcinogenicity | 3.6 | 11,579 | Blocked | Marcus Webb | |
| CC-250 | 5.4.8 | Study Reports – Clinical Pharmacology | 5.7 | HTML | 8,395 | Pending | Carlos Mendez |
| CC-350 | 2.6.5 | Clinical Overview | 1.3 | XML | 12,862 | Failed | Nadia Petrova |
| CC-450 | 3.3.7 | Container Closure System | 4.9 | Word | 2,502 | Completed | Aisha Okonkwo |
| CC-550 | 3.8.3 | Analytical Methods | 12.7 | Word | 9,853 | Approved | Priya Sharma |
| CC-650 | 4.5.6 | Genotoxicity | 1.4 | XML | 9,475 | Draft | Lieselotte van der Berg |
| CC-750 | 1.5.7 | Application Form | 4.0 | HTML | 1,842 | Submitted | Nadia Petrova |
| CC-850 | 2.8.5 | Clinical Summary | 1.4 | 13,493 | Blocked | James O'Brien | |
| CC-950 | 4.4.6 | Toxicology Studies | 1.0 | Word | 7,840 | Active | Lieselotte van der Berg |
| CC-1050 | 2.5.1 | Clinical Overview | 1.4 | Word | 14,169 | Blocked | Marcus Webb |
| CC-1150 | 3.4.6 | Analytical Methods | 6.1 | XML | 3,659 | In Progress | Aisha Okonkwo |
| CC-1250 | 1.9.5 | Prescribing Information | 4.9 | HTML | 4,272 | Active | Tomoko Ikeda |
| CC-1350 | 5.4.3 | Study Reports – Safety | 10.7 | XML | 12,949 | Blocked | Nadia Petrova |
| CC-1450 | 1.2.5 | Proposed Conditions of Approval | 10.1 | 10,146 | In Progress | Marcus Webb | |
| CC-1550 | 4.9.3 | Pharmacokinetics Studies | 2.1 | 13,995 | Pending | Dmitri Volkov | |
| CC-1650 | 5.6.8 | Study Reports – Efficacy | 5.0 | HTML | 1,646 | In Progress | James O'Brien |
| CC-1750 | 4.5.3 | Toxicology Studies | 12.6 | XML | 1,493 | Submitted | James O'Brien |
| CC-1850 | 4.1.6 | Toxicology Studies | 1.9 | HTML | 8,139 | In Progress | Tomoko Ikeda |
| CC-1950 | 5.1.6 | Integrated Summary of Efficacy | 2.8 | Word | 7,843 | Completed | Aisha Okonkwo |
Showing 20 of 20 components