What’s New for Biologics

What’s New for Biologics

• October 5, 2018 Summary Basis of Regulatory Action - GARDASIL 9 (PDF - 86KB)
  Updated: 10/10/2018
• October 2, 2018 Summary Basis of Regulatory Action - IXIARO (PDF - 117KB)
  Updated: 10/10/2018
• October 4, 2018 Approval Letter - Afluria and Afluria Quadrivalent (PDF - 103KB)
  Updated: 10/10/2018
• 2018 Biological License Application Supplement Noteworthy Approvals
  Posted: 10/10/2018; Updated through 9/30/2018
• 2018 Biological Device Application Approvals
  Posted: 10/10/2018; Updated through 9/30/2018