What’s New for Biologics

What’s New for Biologics

• Fast Track Designation Request Performance
  Posted: 7/20/2018
• BK180200: LifeTrak®2018
  Posted: 7/20/2018
• BK170108: Cyclone® Concentrating System
  Posted: 7/20/2018
• Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs); Draft Guidance for Industry (PDF - 578KB)
  Updated: 7/20/2018