FDA-2024-0001
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-001
Application Number
FDA-2024-0001
Procedure Type
Type II Variation
Status
Failed
Linked Product
Market Authorization
United States · FDA
Dossier Structure View
| Dossier | Format | Version | Modules | Module Breakdown | Status |
|---|---|---|---|---|---|
| DOS-001 | NeeS | 6.3.6 | 5 | M1 (13), M2 (7), M3 (7), M4 (4), M5 (14) | Submitted |
Sequence Timeline
Open Questions and Commitments
| Question | Due Date | Risk | Status |
|---|---|---|---|
| Query regarding bioequivalence study design | 2025-03-15 | medium | Draft |
| Information request: manufacturing process change justification | 2025-01-14 | medium | Overdue |
| Question on comparative dissolution data | 2025-02-13 | medium | Draft |
| Query: container closure integrity study methodology | 2025-03-24 | medium | Open |
| Deficiency letter: missing stability data for 40°C condition | 2024-12-23 | high | In Progress |
| Commitment | Due Date | Priority | Status |
|---|---|---|---|
| Provide 36-month accelerated stability data for 25°C/60% RH condition | 2024-10-27 | medium | Blocked |
| Complete Phase IV post-marketing observational study (n=500) | 2024-12-11 | high | Blocked |
| Complete Phase IV post-marketing observational study (n=500) | 2025-08-23 | medium | Overdue |
Linked Labeling and Variations
| Variation | Type | Status | Submitted |
|---|---|---|---|
| FDA-2024-0001-V001 | Minor | Overdue | 2024-04-28 |
| FDA-2024-0001-V101 | Type IA | Pending | 2023-12-07 |
| FDA-2024-0001-V201 | Type IB | Failed | 2023-08-11 |
| FDA-2024-0001-V301 | Major | Approved | 2022-11-07 |
| FDA-2024-0001-V401 | Major | Active | 2024-05-26 |
Inspection Readiness Risk Panel
Risk Score: 3 · Overdue commitments: 1, failed/blocked sequences: 0, high-risk questions: 1.
Recommended next step: resolve outstanding questions and commitments before next publishing cycle to reduce inspection exposure.