US FDA•United StatesCRL•Complete Response Letter
Complete Response Letter BLA 761356 (Apr 12, 2024)
Issued April 12, 2024
Issued
April 12, 2024
Application
BLA • 761356
Review center
CBER
Stage
Final Decision
Letter type
Complete Response Letter
Response due April 12, 2025Requires resubmission addressing deficiencies.
Document viewer
Read the FDA letter and send context to the co-pilot at any time.