Dossier DOS-086
Dossier in NeeS format, version 5.9.7, for application HC-2024-0086. The module tree below shows the 5 CTD modules with their component count and status.
Dossier ID
DOS-086
Format
NeeS
Version
5.9.7
Status
Overdue
Application
Created
2022-06-20
Updated
2023-12-27
Total Modules
5
Module Tree
| Module | Title | Components | Status |
|---|---|---|---|
| 1 | Administrative Information and Prescribing Information | 5 | Active |
| 2 | CTD Summaries | 5 | In Progress |
| 3 | Quality | 8 | In Progress |
| 4 | Nonclinical Study Reports | 13 | Blocked |
| 5 | Clinical Study Reports | 9 | Blocked |
Content Components (showing first 20)
| ID | Section | Title | Version | Format | Words | Status | Owner |
|---|---|---|---|---|---|---|---|
| CC-086 | 3.6.2 | Manufacturing Process | 3.6 | 10,939 | Failed | Dmitri Volkov | |
| CC-186 | 2.4.8 | Clinical Summary | 12.8 | Word | 5,194 | Failed | Nadia Petrova |
| CC-286 | 5.3.5 | Integrated Summary of Safety | 12.1 | XML | 9,503 | Draft | Lieselotte van der Berg |
| CC-386 | 1.4.3 | Patient Labeling | 11.1 | 14,880 | Blocked | Carlos Mendez | |
| CC-486 | 3.1.9 | Stability Data | 6.8 | XML | 10,449 | Completed | Nadia Petrova |
| CC-586 | 3.8.2 | Drug Product | 1.7 | 1,357 | Approved | Priya Sharma | |
| CC-686 | 5.4.7 | Study Reports – Efficacy | 7.1 | XML | 2,363 | Active | Marcus Webb |
| CC-786 | 1.7.7 | Prescribing Information | 3.8 | Word | 7,222 | Active | Lieselotte van der Berg |
| CC-886 | 1.9.2 | Prescribing Information | 5.2 | Word | 6,473 | Overdue | James O'Brien |
| CC-986 | 3.2.5 | Drug Product | 8.4 | 952 | Approved | Carlos Mendez | |
| CC-1086 | 4.7.4 | Pharmacology Studies | 7.5 | Word | 11,758 | Completed | Carlos Mendez |
| CC-1186 | 3.7.1 | Manufacturing Process | 3.6 | 7,119 | Submitted | James O'Brien | |
| CC-1286 | 5.6.2 | Integrated Summary of Safety | 12.2 | XML | 5,602 | Draft | Carlos Mendez |
| CC-1386 | 5.6.2 | Study Reports – Clinical Pharmacology | 1.6 | Word | 9,884 | Draft | Carlos Mendez |
| CC-1486 | 5.5.8 | Study Reports – Clinical Pharmacology | 8.2 | 11,894 | In Progress | Nadia Petrova | |
| CC-1586 | 2.6.5 | Nonclinical Summary | 4.5 | HTML | 5,446 | Approved | Dmitri Volkov |
| CC-1686 | 5.1.1 | Study Reports – Safety | 8.9 | 3,884 | Blocked | Carlos Mendez | |
| CC-1786 | 4.6.2 | Pharmacokinetics Studies | 12.9 | 4,483 | Submitted | Dmitri Volkov | |
| CC-1886 | 2.1.4 | Nonclinical Overview | 9.6 | HTML | 9,808 | Active | Tomoko Ikeda |
| CC-1986 | 3.2.8 | Manufacturing Process | 8.9 | XML | 9,575 | Approved | Aisha Okonkwo |
Showing 20 of 20 components