What’s New for Biologics | FDA

What’s New for Biologics | FDA

• BK190361 - BloodRelay 1.0.0
• 2019 Biological License Application Approvals; Update
• 2019 Biological License Application Supplement Noteworthy Approvals; Update
• 2019 Biological Device Application Approvals; Update
• Influenza Vaccine for the 2019-2020 Season; Update
• September 18, 2019 Approval Letter - Flucelvax

9/20/2019	Interacting with the FDA on Complex Innovative Trial Designs for Drugs and Biological Products; Draft Guidance for Industry
9/19/2019	BK190361 - BloodRelay 1.0.0
9/19/2019	2019 Biological License Application Approvals Update
9/19/2019	2019 Biological License Application Supplement Noteworthy Approvals Update
9/19/2019	2019 Biological Device Application Approvals Update
9/19/2019	Influenza Vaccine for the 2019-2020 Season Update
9/19/2019	September 18, 2019 Approval Letter - Flucelvax
9/17/2019	TCPro simulates immune system response to biotherapeutic drugs
9/16/2019	Expanded Access to Experimental Biologics
9/13/2019	Select CBER Projects and Activities