Vaccines, Blood & Biologics
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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.
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Recently Added
Approval History, Letters, Review, and Related Documents - Flublok
Posted: 2/15/2013Sunrise - Authorization to Resume Operations (PDF - 50KB)
Posted: 2/15/2013Influenza Virus Vaccine for the 2012-2013 Season
Updated: 2/14/2012Applied Biosystems 3500 Dx/3500xL Dx Genetic Analyzer CS2 & 3500 Dx Series Data Collection Software
Posted: 2/13/2013- BK110038 Letter-SeCore® HLA Sequencing System
Posted" 2/13/2013 Oversee Domain Management, LLC - Untitled Letter
Posted: 2/13/2012The 16th US-Japan Cellular and Gene Therapy Conference Agenda
Posted: 2/12/2013The 16th US-Japan Cellular and Gene Therapy Conference
Posted: 2/12/2013Improved characterization of bone marrow stromal stem cells could support their use as safe and effective therapies
Posted: 2/12/2013Phacilitate Vaccine Forum
Posted: 2/9/2013Summary Basis for Regulatory Action, January 16, 2013 - Flublok (PDF - 180KB)
Posted: 2/6/2013Guidance Agenda: Guidance Documents CBER is Planning to Publish During Calendar Year 2013 (PDF - 47KB)
Posted: 2/6/2013HCT/P Inspection Information
Updated: 2/5/2013- BK120048 - Intra-Spin System
Posted: 2/4/2013 February 27, 2013: Vaccines and Related Biological Products Advisory Committee Waiver
Posted: 1/30/2013FDA Pharmacovigilance Course in Sweden (PDF - 12KB)
Posted: 1/29/2013List of Establishments Granted Approval for a Variance to 21CFR640.3(d) and 21CFR640.3(f)
Updated: 1/29/2013January 24, 2013 Approval Letter - Corifact
Posted: 1/29/2013January 25, 2013 Approval Letter - Prevnar 13
Posted: 1/29/2013CBER FY 2012 Recall Postings
Posted: 1/28/2013February 27, 2013: Vaccines and Related Biological Products Advisory Committee Meeting Announcement
Posted: 1/28/20137342.001 - Inspection of Licensed and Unlicensed Blood Banks, Brokers, Reference Laboratories, and Contractors
Updated: 1/28/2013- BK120047 - Autopheresis-C Plasampheresis System Plasmacell-C Set
Posted: 1/25/2013 - BK120064 - Donor Information System (DIS) v6.0
Posted: 1/25/2013 - BK120024 - LABType ® SSO DNA Typing Tests for use with LABScan™3D
Posted: 1/24/2013 - BK120082 - AMICUS Apheresis Kits; AMICUS Separator System
Posted: 1/24/2013 January 22, 2013 Approval Letter - Prevnar 13
Posted: 1/24/2013Approval History, Letters, Review, and Related Documents - Bivigam
Posted: 1/18/2013- BK120035 - Picture - ID Version 2.0
Posted: 1/18/2013 Approval History, Letter, Reviews, and Related Documents - VARIZIG
Posted: 1/18/2013January 17, 2013 Approval Letter-Octaplas (PDF - 116KB)
Posted: 1/18/2013Octaplas
Posted: 1/18/2013- January 16, 2013 Approval Letter-Flublok (PDF - 121KB)
Posted: 1/17/2013 Flublok
Posted: 1/17/2013February 12, 2013: Blood Products Advisory Committee Meeting Waivers for Conflicts of Interest
Posted: 1/17/2013February 12, 2013: Blood Products Advisory Committee Meeting Announcement
Posted: 1/17/2013Clinical Investigator Status (Biologics)
Updated: 1/16/2013Medical Officer (OBE)
Posted: 1/15/2013January 15, 2013: Cellular, Tissue and Gene Therapies Advisory Committee Meeting Agenda
Updated: 1/9/2013January 15, 2013: Cellular, Tissue and Gene Therapies Advisory Committee Meeting Draft Roster
Updated: 1/9/20132012 Biological License Application Supplement Approvals
Updated: 1/9/20132012 Biological License Application Supplement Approvals
Updated: 1/9/20132012 Biological Device Application Approvals
Updated: 1/9/2013Tissue Reference Group
Updated: 12/31/2012November 14, 2012: Vaccines and Related Biological Products Advisory Committee Meeting Summary Minutes (PDF - 55KB)
Posted: 12/31/2012November 14, 2012: Vaccines and Related Biological Products Advisory Committee Meeting Transcripts (PDF - 460KB)
Posted: 12/31/2012November 15, 2012: Vaccines and Related Biological Products Advisory Committee Meeting Transcripts (PDF - 350KB)
Posted: 12/31/2012
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