FDA-2024-0081
This application view consolidates identifiers, linked product and market authorization context, dossier structure, sequence history, and active authority obligations in one place. Regulatory teams use it to understand readiness and risk before publishing new sequences or responding to open questions. Cross-links to labeling and variations maintain lifecycle traceability for post-approval changes. Inspection readiness risk is calculated from overdue commitments, failed sequences, and unresolved high-risk correspondence for immediate action.
Application ID
APP-081
Application Number
FDA-2024-0081
Procedure Type
NDA
Status
Completed
Linked Product
Market Authorization
Turkey · FDA
Dossier Structure View
| Dossier | Format | Version | Modules | Module Breakdown | Status |
|---|---|---|---|---|---|
| DOS-081 | NeeS | 7.1.2 | 5 | M1 (9), M2 (13), M3 (12), M4 (12), M5 (10) | Overdue |
Sequence Timeline
Open Questions and Commitments
| Question | Due Date | Risk | Status |
|---|---|---|---|
| Request for additional clinical data on primary endpoint | 2025-03-19 | low | Open |
| Information request: extractables and leachables data | 2025-04-09 | medium | Open |
| Information request: extractables and leachables data | 2025-04-05 | low | Draft |
| Information request: manufacturing process change justification | 2024-12-11 | medium | Draft |
| GMP inspection findings clarification | 2025-03-31 | high | In Progress |
| Commitment | Due Date | Priority | Status |
|---|---|---|---|
| Update SmPC section 4.4 with hepatic impairment data | 2025-08-14 | medium | Blocked |
| Submit harmonised global label per ICH Q12 PLCR | 2025-08-23 | low | Open |
| Complete Phase IV post-marketing observational study (n=500) | 2025-01-27 | medium | Overdue |
| Update SmPC section 4.4 with hepatic impairment data | 2025-04-24 | low | Overdue |
Linked Labeling and Variations
| Labeling Artifact | Type | Version | Status |
|---|---|---|---|
| LBL-241 | PIL | 15.3 | Submitted |
| LBL-242 | IFU | 15.8 | Approved |
| LBL-243 | SmPC | 20.4 | In Progress |
| Variation | Type | Status | Submitted |
|---|---|---|---|
| FDA-2024-0081-V081 | Minor | Completed | pending |
| FDA-2024-0081-V181 | Minor | Completed | pending |
| FDA-2024-0081-V281 | Minor | Completed | pending |
| FDA-2024-0081-V381 | Type IA | Overdue | pending |
| FDA-2024-0081-V481 | Type II | Blocked | 2022-11-25 |
Inspection Readiness Risk Panel
Risk Score: 5 · Overdue commitments: 2, failed/blocked sequences: 0, high-risk questions: 1.
Recommended next step: resolve outstanding questions and commitments before next publishing cycle to reduce inspection exposure.