What’s New for Biologics
Items related to biologics will be added to the top of the list as they are posted on the site.
Recently Added
November 9, 2018 Summary Basis for Regulatory Action - ORALAIR (PDF - 151KB)
Posted: 11/13/2018November 9, 2018 Approval Letter - ORALAIR (PDF - 107KB)
Posted: 11/13/2018- 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Posted: 11/8/2018 Considerations for the Development of Dried Plasma Products Intended for Transfusion; Draft Guidance for Industry (PDF - 104KB)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: 10/29/2018October 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: 10/15/2018October 11, 2018 Untitled Letter - Registrant of www.ollereg.com (PDF - 42KB)
Posted: 10/15/2018October 11, 2018 Approval Order - ID CORE XT (PDF - 54KB)
Posted: 10/12/2018Statistical Review - Afluria Quadrivalent(125254-692) (PDF - 533KB)
Posted: 10/11/2018Statistical Review Addendum - Afluria Quadrivalent ( 125254-692) (PDF - 256KB)
Posted: 10/11/2018Clinical Review - Afluria Quadrivalent (125254-692) (PDF - 1.1MB)
Posted: 10/11/2018October 3, 2018 Summary Basis for Regulatory Action- Afluria Quadrivalent (PDF - 235KB)
Posted: 10/11/2018October 5, 2018 Summary Basis of Regulatory Action - GARDASIL 9 (PDF - 86KB)
Updated: 10/10/2018October 2, 2018 Summary Basis of Regulatory Action - IXIARO (PDF - 117KB)
Updated: 10/10/2018October 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
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