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Approval Information: Human Immunodeficiency Virus, Type 1 (HIV-1) Reverse Transcription (RT) Polymerase Chain Reaction (PCR) assay- Summary Basis for Approval
Posted: 1/15/2009
Vacancy Announcement - Director, DH/OBRR
Posted: 1/15/2009
Fast Track Designation Request Performance Report - Update
Posted: 1/12/2009
Approved Premarket Approval (PMA) Device Applications - Update
Posted: 1/8/2009
Substantially Equivalent 510(k) Device Applications - Update
Posted: 1/8/2009
Approved NDA and ANDA Applications - Update
Posted: 1/8/2009
Approval Information- (ANDA) Anticoagulant Citrate Phosphate Dextrose Solution (CPD)
Posted: 1/8/2009 Approved: 1/6/2009
Biological Product Shortages - Recombivax HB (Merck & Co.)
Posted: 1/7/2009
Meeting of the Blood Products Advisory Committee - Updated
Posted: 1/6/2009
Draft Guidance for Industry and FDA Staff: Assay Migration Studies for In Vitro Diagnostic Devices
Posted: 1/5/2009
Adjuvants and Adjuvanted Preventative and Therapeutic Vaccines for Infectious Disease Indications - Presentations
Posted: 1/2/2009
Approval Information: Human Immunodeficiency Virus Type 1 (HIV-1) Group M RNA, HIV-1 Group O RNA,
Human Immunodeficiency Virus Type 2 (HIV-2) RNA, Hepatitis C Virus (HCV) RNA and Hepatitis B Virus (HBV) DNA Assay - COBAS TaqScreen MPX Test
Posted: 12/31/2008
FDA Approves First Nucleic Acid Test to Screen for Additional Types of HIV in Donated Blood and Tissue
Posted: 12/31/2008
CBER Organizational Charts
Posted: 12/29/2008
Vacancy Announcement - Director, DHT/OCTGT
Posted: 12/23/2008
Vacancy Announcement - Supervisory Genetic Epidemiologist, OBE
Posted: 12/23/2008
Substantially Equivalent 510(k) Device -Arthrex Double Syringe (ACP, Autologous Conditioned Plasma) System - Arthrex Incorporated
Posted: 12/19/2008, Clearance Date: 12/12/2008
Electronic Biological Product Deviation Reporting (eBPDR) Instructions for Using the eBPDR System - Update
Posted: 12/19/2008
Electronic Biological Product Deviation Reporting (eBPDR) Latest System Changes - Update
Posted: 12/19/2008
Draft Guidance for Industry on Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic; Availability
Posted: 12/19/2008
Vacancy Announcement - Pharmacology/Toxicology Reviewer, DCEPT/OCTGT
Posted: 12/18/2008
Influenza Virus Vaccine 2008/2009 Season Lot Release Status - Update
Posted: 12/17/2008
Approval Information: Anthrax Vaccine Adsorbed (Biothrax) Revised Package Insert - Update
Posted: 12/15/2008
Approval Information: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (BOOSTRIX ®) - Update
Posted: 12/12/2008
Approval Information: Tetanus and Diphtheria Toxoids Adsorbed, DECAVAC ® - Revised Package Insert - Update
Posted: 12/12/2008
Vacancy Announcement - Mathematical Statistician, OBE
Posted: 12/11/2008
Current Licensed Establishments and Products - Alphabetical List of Licensed Establishments - Updated
Posted: 12/10/2008
Current Licensed Establishments and Products - Listed by Product - Updated
Posted: 12/10/2008
Influenza Virus Vaccine 2008/2009 Season Lot Release Status - Update
Posted: 12/10/2008
Blood Products Advisory Committee Meeting
Posted: 12/09/2008
Vacancy Announcement - Postdoctoral Fellowship, LBP/DBPAP/OVRR
Posted: 12/05/2008
Approval Information: Zoster Vaccine Live - Revised package insert for Frozen Formulation - Update
Posted: 12/04/2008
Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics
Posted: 12/04/2008