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Vaccines, Blood & Biologics
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Resources for You
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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
- Jobs at the Center for Biologics Evaluation and Research (CBER)
Biologist (OVRR/DVR/LRR), Posted: 8/24/2009 - Jobs at the Center for Biologics Evaluation and Research (CBER)
Medical Officer and Interdisciplinary Scientist (OCTGT), Posted: 8/21/2009 - Gardasil Vaccine Safety
Posted: 8/20/2009 - Hiberix - Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)
Posted: 8/19/2009 - Influenza Virus Vaccine for the 2009-2010 Season
Lot release information, Updated: 8/19/2009 - 2009 Meeting Materials of the Blood Products Advisory Committee
Transcripts of the 7/20-21/2009 Meeting, Posted: 8/18/2009 - Public Workshop: FDA Regulation and Licensure of Whole Blood and Blood Components
Agenda, Posted: 8/18/2009 - Complete List of Substantially Equivalent 510(k) Device Applications (PDF - 862KB)
Updated: 8/18/2009 - Complete List of Currently Approved Premarket Approvals (PMAs) (PDF - 37KB)
Updated: 8/18/2009 - Complete List of Currently Approved NDA and ANDA Application Submissions (PDF - 165KB)
Updated: 8/18/2009 - Complete List of Licensed Products and Establishments
Updated: 8/18/2009 - 2009 Meeting Materials, Vaccines and Related Biological Products Advisory Committee
9/9/2009 Vaccines and Related Biological Products Meeting Announcement, Posted: 8/17/2009 - Jobs at the Center for Biologics Evaluation and Research (CBER)
Interdisciplinary (Principal Investigator) (OBRR), Posted: 8/13/2009 - Access to Investigational Drugs
Posted: 8/12/2009 - 2009 Meeting Materials, Vaccines and Related Biological Products Advisory Committee
July 23, 2009 Meeting Transcript, Updated: 8/7/2009 - Bone Marrow Collection/Transfusion Kit
BK090031 - Substantially Equivalent 510(k) Device Information, Posted: 8/7/2009 - Menactra
Meningococcal Polysaccharide (Serogroups A, C, Y and W-135) Diphtheria Toxoid Conjugate Vaccine, Posted: 8/6/2009 - Influenza Virus Vaccine for the 2009-2010 Season
Lot release information, Updated: 8/5/2009 - Jobs at the Center for Biologics Evaluation and Research (CBER)
Program Analyst (OM), Posted: 8/5/2009 - Jobs at the Center for Biologics Evaluation and Research (CBER)
Health Science Administrator (OM), Posted: 8/5/2009 - FDA-NCI Workshop on Therapeutic Cancer Vaccines
Posted: 8/5/2009 - Zostavax
Posted: 8/3/2009 - C1 Esterase Inhibitor (Human)(Cinryze) Untitled Letter
Posted: 7/30/2009 - Influenza Virus Vaccine for the 2009-2010 Season
Lot release information, Updated: 7/30/2009 - Exceptions and Alternative Procedures Approved Under 21 CFR 640.120
Updated: 7/28/2009 - Guidance for Industry: Nucleic Acid Testing (NAT) to Reduce the Possible Risk of Parvovirus B19 Transmission by Plasma-Derived Products
Posted: 7/28/2009 - Immune Globulin Intravenous (Human), 10 Percent Caprylate/Chromatography Purified (Gamunex) Untitled Letter
Posted: 7/24/2009 - InVitro Diagnostics Untitled Letter
Posted: 7/23/2009 - Complete List of Substantially Equivalent 510(k) Device Applications (PDF - 862KB)
Updated: 7/21/2009 - Complete List of Currently Approved NDA and ANDA Application Submissions (PDF - 165KB)
Updated: 7/21/2009 - Complete List of Currently Approved Premarket Approvals (PMAs) (PDF - 37KB)
Updated: 7/21/2009 - Direct Recall Classification Program (Blood and Plasma)
Posted: 7/21/2009 - BK090010 - Biomixer BM330 with XBee (Wireless) Option
Posted: 7/21/2009
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Recalls & Alerts
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Contact Us
- (800) 835-4709
- (301) 827-1800
- ocod@fda.hhs.gov
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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