MFDS-2020-0010
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-010
Application Number
MFDS-2020-0010
Procedure Type
NDS
Status
Approved
Linked Product
Market Authorization
Germany · MFDS
Dossier Structure View
| Dossier | Format | Version | Modules | Module Breakdown | Status |
|---|---|---|---|---|---|
| DOS-010 | CTD | 5.4.8 | 5 | M1 (10), M2 (3), M3 (13), M4 (12), M5 (12) | In Progress |
Sequence Timeline
Open Questions and Commitments
| Question | Due Date | Risk | Status |
|---|---|---|---|
| Request for benefit-risk assessment addendum | 2024-12-16 | low | In Progress |
| Request for benefit-risk assessment addendum | 2024-12-27 | high | Draft |
| Request for post-marketing commitment progress update | 2025-03-07 | high | In Progress |
| Query: container closure integrity study methodology | 2025-01-31 | medium | Open |
| Request for additional clinical data on primary endpoint | 2025-03-26 | medium | Open |
| Commitment | Due Date | Priority | Status |
|---|---|---|---|
| Complete Phase IV post-marketing observational study (n=500) | 2025-09-27 | medium | Blocked |
| Provide carcinogenicity study report for 2-year rat study | 2025-01-26 | high | Open |
| Provide carcinogenicity study report for 2-year rat study | 2025-07-21 | medium | Blocked |
Linked Labeling and Variations
| Variation | Type | Status | Submitted |
|---|---|---|---|
| MFDS-2020-0010-V010 | Type IA | Failed | 2024-01-29 |
| MFDS-2020-0010-V110 | Type II | Approved | 2024-01-17 |
| MFDS-2020-0010-V210 | Type IA | Blocked | pending |
| MFDS-2020-0010-V310 | Minor | Submitted | 2024-05-18 |
| MFDS-2020-0010-V410 | Major | Approved | 2023-01-20 |
Inspection Readiness Risk Panel
Risk Score: 4 · Overdue commitments: 0, failed/blocked sequences: 1, high-risk questions: 2.
Recommended next step: resolve outstanding questions and commitments before next publishing cycle to reduce inspection exposure.