Regulations.gov document
Determination of Regulatory Review Period for Purposes of Patent Extension; ROMVIMZA
Notice · FDA-2025-E-0923 · posted Dec 29, 2025
Key facts
| Document ID | FDA-2025-E-0923-0006 |
|---|---|
| Title | Determination of Regulatory Review Period for Purposes of Patent Extension; ROMVIMZA |
| Document type | Notice |
| Subtype | Determinations |
| Agency | FDA |
| Docket | FDA-2025-E-0923 |
| Posted | Dec 29, 2025 |
| Federal Register citation | 90 FR 60721 |
| FR document number | 2025-23862 |
| Comment period opens | Dec 29, 2025 |
| Comments due | Feb 28, 2026 |
| Effective date | Dec 29, 2025 |
At a glance
- 1–9 Pages
- No Open for comment
- None Public comments on this docket
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