FDA-2024-0061-V361
Major variation for application FDA-2024-0061. Major variation: Analytical Method Change for Kcluximab — critical change
Variation Number
FDA-2024-0061-V361
Type
Major
Application
Change
Status
Failed
Fee
€47,340
Submitted
—
Approved
—
Description
Major variation: Analytical Method Change for Kcluximab — critical change