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
Research Fellowship (OVRR)
Posted: 10/12/2012- BK120042 - DailyChek QC Kit
Posted: 10/12/2012 Biologic Product Shortages
Updated: 10/12/2012- BK120040 - Trima Accel® System
Posted 10/11/2012 - BK120041 - AMICUS Separator System; ALYX Component System
Posted: 10/11/2012 Roster of the Allergenic Products Advisory Committee
Updated: 10/10/2012Influenza Virus Vaccine for the 2012-2013 Season
Updated: 10/10/2012Blood Grouping Reagent, Anti-K ALBAsera®
Alba Bioscience Limited, Posted: 10/9/2012Blood Grouping Reagent, Anti-Fya ALBAsera®
Alba Bioscience Limited, Posted: 10/9/2012Blood Grouping Reagent, Anti-Fyb ALBAsera®
Alba Bioscience Limited, Posted: 10/9/2012Blood Grouping Reagents, Anti-Wra ALBAsera®
Alba Bioscience Limited, Posted: 10/9/2012Blood Grouping Reagent, Anti-s ALBAsera®
Alba Bioscience Limited, Posted: 10/9/2012- Public Workshop: Use of Computer Simulation of the United States Blood Supply in support of Planning for Emergency Preparedness and Medical Countermeasures - Transcript (PDF - 263KB)
Posted: 10/5/2012 Ducord, HPC Cord Blood
Hematopoietic Progenitor Cell, Posted: 10/5/2012Information for Blood Establishments: Unavailability of CHIRON® RIBA® HCV 3.0 SIA (RIBA)
Posted: 10/4/2012User Fee Billable Biologic Products and Potencies Approved Under Section 351 of the PHS Act
Updated: 10/3/20122012 Meeting Materials, Vaccines and Related Biological Products Advisory Committee
September 19, 2012 Meeting Materials Updated: 10/3/2012Clinical Investigator Status (Biologics)
Updated: 10/3/2012Exceptions and Alternative Procedures Approved Under 21 CFR 640.120
Updated: 10/2/2012Recall of Thymoglobulin [Anti-thymocyte Globulin (Rabbit)] 25mg/vial
Posted: 8/28/2012September 26, 2012 Approval Letter - Boostrix
Posted: 10/1/2012Biological Product Deviation Reporting and HCT/P Deviation Reporting - Deviation Codes
Updated: 10/1/2012Important Product Information – Evicel and Evithrom
Posted: 10/1/20127342.008 - Inspection of Licensed In-Vitro Diagnostic (IVD) Devices Regulated by CBER
Updated: 10/1/2012- Public Workshop: Risks and Benefits of Hydroxyethyl Starch Solutions - September 7, 2012 Transcript (PDF - 359KB)
Posted: 9/28/2012 - Public Workshop: Risks and Benefits of Hydroxyethyl Starch Solutions - September 6, 2012 Transcript (PDF - 800KB)
Posted: 9/28/2012 Recall of Typhim Vi, Typhoid Vi Polysaccharide Vaccine
Posted: 9/28/2012- BK120036 - HCLL™ Transfusion
Posted: 9/28/2012 Influenza Virus Vaccine for the 2012-2013 Season
Updated: 9/27/2012- BK120039 - LifeTrak Version 2012
Posted: 9/25/2012 Biological Product Deviation Reporting and HCT/P Deviation Reporting - Non-Blood Product Codes
Updated: 9/25/2012Final Guidance for Industry: Pre-Storage Leukocyte Reduction of Whole Blood and Blood Components Intended for Transfusion.
Posted: 9/25/20122012 Biological License Application Supplement Approvals
Posted: 9/21/20122012 Biological Device Application Approvals
Posted: 9/21/2012- BK110071 - TSCD®II Sterile Tubing Welder with or without Trucise® Total System
Posted: 9/21/2012 Influenza Virus Vaccine for the 2012-2013 Season
Updated: 9/19/2012FDA Basics – OCTGT Webinar on Tissue Safety
Posted: 9/19/2012- September 20-21, 2012: 2012 Meeting Materials, Blood Products Advisory Committee: Octapharma Issue Summary (PDF - 231KB)
Persons with disabilities having problems accessing the PDF may call 301-827-0314 for assistance.; Posted: 9/18/2012 - September 20-21, 2012: 2012 Meeting Materials, Blood Products Advisory Committee: Topic 2 Issue Summary (PDF - 537KB)
Posted: 9/18/2012 Supporting the Development of Mesenchymal Stem Cells as Medical Therapies
Research Summary; Posted: 9/17/2012September 14, 2012 Approval Letter - Prevnar 13
Approval Letter and Package Insert, Posted: 9/17/2012Developing Gene Therapy for Cancers Using Virus Vectors
Research Summary; Posted: 9/17/2012September 14, 2012 Approval Letter - Imovax
Approval Letter and Package Insert, Posted: 9/17/2012- September 19, 2012: Vaccines and Related Biological Products Advisory Committee: FDA Briefing Document: Cell Lines Derived from Human Tumors for Vaccine Manufacture (PDF - 209KB)
Posted: 9/17/2012 - September 19, 2012: Vaccines and Related Biological Products Advisory Committee: Meeting Roster (PDF - 26KB)
Posted: 9/15/2012 - September 19, 2012: Vaccines and Related Biological Products Advisory Committee: Draft Agenda (PDF - 26KB) (PDF - 26KB)
Posted: 9/15/2012 - September 19, 2012: Vaccines and Related Biological Products Advisory Committee: Meeting Roster (PDF - 26KB) (PDF - 27KB)
Posted: 9/15/2012 - September 20-21, 2012: Blood Products Advisory Committee Meeting: Topic I: "Hepatitis E Virus (HEV) and Blood Transfusion Safety (PDF - 326KB)
Posted: 9/14/2012 - September 20-21, 2012: Blood Products Advisory Committee Meeting: Topic 3: Issue Summary: "Considerations for Strategies to Further Reduce the Risk of Bacterial Contamination in Platelets" (PDF - 66KB)
Posted: 9/14/2012 - September 20-21, 2012: Blood Products Advisory Committee Meeting: Draft Agenda (PDF - 23KB)
Posted: 9/14/2012 - DoVac Elite 1.0
Software, Blood Bank, Stand Alone
Posted: 9/14/2012 FDA Basics – OCTGT Webinar on Tissue Safety
Posted: 9/12/2012Update: Information on Rotarix - Labeling Revision Pertaining to Intussusception
Posted: 9/7/2012September 7, 2012 Approval Letter - Rotarix
Posted: 9/7/2012Influenza Virus Vaccine for the 2012-2013 Season
Updated: 9/12/2012September 10, 2012 Approval Letter - Boostrix
Posted: 9/11/20122012 Meeting Materials, Vaccines and Related Biological Products Advisory Committee September 20-21, 2012 Blood Products Advisory Committee Meeting: Waivers for Conflicts of Interest
Posted: 9/4/2012Impact of Severe Weather Conditions on Biological Products
Updated: 8/30/2012Influenza Virus Vaccine for the 2012-2013 Season
Updated: 8/29/2012
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Contact FDA
(800) 835-4709
(301) 827-1800
Consumer Affairs Branch (CBER)
Division of Communication and Consumer Affairs
Office of Communication, Outreach and Development
Food and Drug Administration
1401 Rockville Pike
Suite 200N/HFM-47
Rockville, MD 20852-1448
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