All regulations
Nonrulemaking
FDA
FDA-2026-N-4588
Issuance of Priority Review Voucher; Rare Pediatric Disease Product; OTARMENI (lunsotogene parvec-cwha)
Documents
1
Comments
0
Key Dates
Comment Period OpensMay 6, 2026
Documents
| Type | Title | Status |
|---|---|---|
Notice |
Keywords
2026-222
CBER
Issuance of Priority Review Voucher
Rare Pediatric Disease Product
OTARMENI lunsotogene parvec-cwha
OPEN
Data from Regulations.gov