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Vacancy Announcement - Biologist, LBVB/DH/OBRR
Posted: 5/11/2009
Vaccines and Related Biological Products Advisory Committee Roster - Update
Posted: 5/11/2009
Approval Information - Rotavirus Vaccine, Live, Oral (Rotarix) Package Insert - Update
Posted: 5/7/2009
2009 H1N1 Flu Virus - Update "FDA Approves New Influenza Vaccine Production Facility"
Posted: 5/7/2009
Meeting of the Transmissible Spongiform Encephalopathies Advisory Committee
Posted: 5/6/2009; Meeting Date: 6/12/2009
FEDERAL REGISTER: Revision of the Requirements for Publication of License Revocation; Final Rule -(PDF - 58KB)
Posted: 5/6/2009
FEDERAL REGISTER: Revision of the Requirements for Publication of License Revocation; Companion Document to Direct Final Rule; Proposed Rule - (PDF - 54KB)
Posted: 5/6/2009
Vacancy Announcement - Staff Fellow (Statistics), OBE
Posted: 5/5/2009
Human Cell, Tissues and Cellular and Tissue-Based Products (HCT/P) Alphabetical List of Registered Establishments - Update
Posted: 5/4/2009
Vacancy Announcement - Pre-Doctoral or Post-Doctoral Position, LH/DH/OBRR
Posted: 5/4/2009
Vacancy Announcement - Medical Officer, DH/OBRR - Updated Closing Date
Posted: 5/4/2009
Information about Newly Emerging 2009 H1N1 Influenza Virus and Blood Safety
Posted: 4/30/2009
2009 Biological License Application Supplement Noteworthy Approvals - Update
Posted: 4/30/2009
2009 Biological Device Application Approvals - Update
Posted: 4/30/2009
2009 Biological License Application Approvals - Update
Posted: 4/30/2009
Approval Information - Approval History, Letters, Reviews, and Related Documents (Ixiaro)
Posted: 4/29/2009
Public Workshop: Improving Endpoints, Improving Care: Alpha-1 Antitrypsin Augmentation Therapy and Clinical Trials
Posted: 4/28/2009; Workshop Date: March 23-24, 2009
Meeting of the Cellular, Tissue and Gene Therapies Advisory Committee
Posted: 4/27/2009; Meeting Date: May 14-15, 2009
Substantially Equivalent 510(k) Device - FETALSCREEN™ II - Alba Bioscience
Posted:4/24/2009 Clearance Date: 4/8/2009
Untitled Letter: Influenza Virus Vaccine Live, Intranasal (FluMist)
Posted: 4/24/2009
Approval Information - Summary Basis for Regulatory Action, JEV, Inactivated, Adsorbed (Ixiaro)
Posted: 4/17/2009
Fast Track Designation Performance Report - Update
Posted 4/13/2009
List of Substantially Equivalent 510(k) Devices - Update
Posted 4/10/2009
List of Approved NDA and ANDA Applications - Update
Posted: 4/10/2009
List of Premarket Approval Information - Devices - Update
Posted: 4/10/2009
Approval Information - Influenza Virus Vaccine (Fluarix) - Update
Posted: 4/10/2009
Biological Product Shortages - Immune Globulin (Human) [GamaSTAN® S/D], Talecris Biotherapeutics, Inc.
Posted: 4/10/2009
Current Licensed Establishments and Products Listed by Product
Posted: 4/9/2009
Vacancy Announcement - Medical Officer, DH/OBRR
Posted: 4/8/2009