FDA-2024-0021
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-021
Application Number
FDA-2024-0021
Procedure Type
sBLA
Status
In Progress
Linked Product
Market Authorization
Turkey · FDA
Dossier Structure View
| Dossier | Format | Version | Modules | Module Breakdown | Status |
|---|---|---|---|---|---|
| DOS-021 | CTD | 4.9.0 | 5 | M1 (6), M2 (6), M3 (14), M4 (9), M5 (3) | Submitted |
Sequence Timeline
Open Questions and Commitments
| Question | Due Date | Risk | Status |
|---|---|---|---|
| Request for updated SmPC section 4.1 | 2024-12-25 | medium | In Progress |
| Query: container closure integrity study methodology | 2024-12-31 | low | Open |
| Question on comparative dissolution data | 2024-12-12 | low | Draft |
| Request for additional clinical data on primary endpoint | 2024-12-26 | low | In Progress |
| Request for benefit-risk assessment addendum | 2025-01-08 | high | Draft |
| Commitment | Due Date | Priority | Status |
|---|---|---|---|
| Submit final study report for paediatric use study KCL-PED-001 | 2025-07-02 | high | Overdue |
| Provide 36-month accelerated stability data for 25°C/60% RH condition | 2025-05-05 | medium | Open |
| Submit annual PSUR covering the period Jan 2024 – Dec 2024 | 2025-09-02 | medium | Blocked |
| Submit harmonised global label per ICH Q12 PLCR | 2025-10-24 | low | Blocked |
Linked Labeling and Variations
| Variation | Type | Status | Submitted |
|---|---|---|---|
| FDA-2024-0021-V021 | Minor | Failed | 2022-08-29 |
| FDA-2024-0021-V121 | Type IA | Approved | pending |
| FDA-2024-0021-V221 | Major | Active | 2023-04-27 |
| FDA-2024-0021-V321 | Minor | Active | pending |
| FDA-2024-0021-V421 | Type IA | Approved | 2023-12-05 |
Inspection Readiness Risk Panel
Risk Score: 5 · Overdue commitments: 1, failed/blocked sequences: 1, high-risk questions: 1.
Recommended next step: resolve outstanding questions and commitments before next publishing cycle to reduce inspection exposure.