Vaccines, Blood & Biologics
-
?
-
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 14-15, 2012: Vaccines and Related Biological Products Advisory Committee Meeting Announcement
Posted: 10/19/2012November 29, 2012: Cellular, Tissue and Gene Therapies Advisory Committee Meeting Announcement
Posted: 10/19/2012Influenza Virus Vaccine for the 2012-2013 Season
Updated: 10/17/2012Research 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: 10/10/2012Blood 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
-
?
?
?
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
-
-