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- Importance of Influenza Vaccination for Health Care Personnel
- Kogenate FS [Antihemophilic Factor (Recombinant]
- Cinryze (C1 Esterase Inhibitor (Human)
- Influenza Virus Vaccine 2008-2009 Season
- GARDASIL (Human Papillomavirus Vaccine)
- Zostavax (Herpes Zoster Vaccine)
- Advisory Committees
- Blood Establishment Registration
- Certification to Accompany Biological Product Submissions
- Forms
- Guidances/Guidelines/Points to Consider
- Impact of Severe Weather Conditions on Biological Products
- Proposed and Final Rules
- Human Cell and Tissue Establishment Registration
- Recall & Product Withdrawals
- Reporting Adverse Events and Product Deviations
- Safety Information
- Shortages
Vaccines and Related Biological Products Advisory Committee
Roster - Update
Posted: 1/30/2009
Posted: 1/30/2009
Supplement Approval: Pneumococcal Vaccine, Polyvalent (Pneumovax
23) - Merck & Co., Inc.
Posted: 1/30/2009 Approved: 1/16/2009
Variances for Collection of Blood and Blood Products from
Patients with Hemochromatosis - Update
Posted: 1/29/2009
Exceptions and Alternative Procedures Approved Under 21 CFR
640.120 - Update
Posted: 1/29/2009
Substantially Equivalent 510(k) Device Applications -
Clotalyst and GPS III Platelet Concentrate Separation Kit
with ACD-A, Clotalyst and GPS III Mini Platelet Concentrate
Separation Kit with ACD-A - Biomet Biologics,
Incorporated
Posted: 1/28/2009 Clearance Date: 12/19/2008
Substantially Equivalent 510(k) Device Applications -
Leucolab LCG2 Leukoreduction System for AS-1, AS-3, and AS-5
Red Blood Cells - MacoProductions S.A.S.
Posted: 1/28/2009 Clearance Date: 1/15/2009
Substantially Equivalent 510(k) Device Applications -
TRUGENE® HIV-1 Genotyping Kit and OpenGene® DNA Sequencing
System - Siemens Healthcare Diagnostics Inc.
Posted: 1/27/2009 Clearance Date: 1/15/2009
Biological Product Shortages - Antivenin - Black Widow
Spider Antivenin (Merck)
Posted: 1/27/2009
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