What’s New for Biologics

What’s New for Biologics

Recently Added

• BK180243 - NEO Iris (Software Version 3.0) 
  Posted: 11/9/2018
• BK180268 - Aurora XI Plasmapheresis System, version 1.2 
  Posted: 11/9/2018
• BK180246 - Blood Bank Information System (BBIMS) version 2.06.00 
  Posted: 11/8/2018
• Influenza Virus Vaccine for the 2018-2019 Season 
  Updated: 11/8/2018
• BK180240 - GDS (Grifols Donation System), version 1.0 
  Posted: 11/8/2018
• BK170092 - ID CORE CONTROL 
  Posted: 11/8/2018
• Considerations for the Development of Dried Plasma Products Intended for Transfusion; Draft Guidance for Industry (PDF - 104KB) 
  Posted: 10/29/2018
• October 23, 2018 Approval Letter - PROQUAD (PDF - 34KB) 
  Posted: 10/24/2018
• BK180232 - Patient Health Software (P.H.S) Version 2.0 
  Posted: 10/23/2018
• October 19, 2018 Approval Letter - Varivax (PDF - 102KB) 
  Posted: 10/22/2018
• BK180229 - HemoMix 3 with DCSX Software 
  Posted: 10/22/2018
• CBER-Regulated Products: Current Shortages 
  Posted: 10/18/2018; Information on Immune Globulin Intravenous (Human) - Gammaplex
• Summary of Safety and Effectiveness Data - ID CORE XT (PDF - 524KB) 
  Posted: 10/17/2018
• BK180227 - VistA Blood Establishment Computer (VBECS) Version 2.3.0 
  Posted: 10/16/2018
• BK180226 - IH-Com V5.0 
  Posted: 10/16/2018
• BK180225 - IH-Reader 24 
  Posted: 10/16/2018
• Clinical Investigator Status (Biologics) 
  Posted: 10/16/2018; Updated through 9/30/2018
• Clinical Review - COAGADEX (PDF - 567KB) 
  Updated: 10/15/2018
• October 11, 2018 Untitled Letter - Registrant of www.ollereg.com (PDF - 42KB) 
  Posted: 10/15/2018
• October 11, 2018 Approval Order - ID CORE XT (PDF - 54KB) 
  Posted: 10/12/2018
• Statistical Review - Afluria Quadrivalent(125254-692) (PDF - 533KB) 
  Posted: 10/11/2018
• Statistical Review Addendum - Afluria Quadrivalent ( 125254-692) (PDF - 256KB) 
  Posted: 10/11/2018
• Clinical Review - Afluria Quadrivalent (125254-692) (PDF - 1.1MB)
  Posted: 10/11/2018
• October 3, 2018 Summary Basis for Regulatory Action- Afluria Quadrivalent (PDF - 235KB) 
  Posted: 10/11/2018
• 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