Regulations.gov document
Determination of Regulatory Review Period for Purposes of Patent Extension; IMDELLTRA
Notice · FDA-2024-E-4366 · posted Jul 14, 2025
Key facts
| Document ID | FDA-2024-E-4366-0006 |
|---|---|
| Title | Determination of Regulatory Review Period for Purposes of Patent Extension; IMDELLTRA |
| Document type | Notice |
| Subtype | Determinations |
| Agency | FDA |
| Docket | FDA-2024-E-4366 |
| Posted | Jul 14, 2025 |
| Federal Register citation | 90 FR 31215 |
| FR document number | 2025-13043 |
| Comment period opens | Jul 14, 2025 |
| Comments due | Sep 13, 2025 |
| Effective date | Jul 14, 2025 |
At a glance
- 1–9 Pages
- No Open for comment
- None Public comments on this docket
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