Recently Added

• Influenza Virus Vaccine Actions 
  Updated: 11/20/2009
• Complete List of Substantially Equivalent 510(k) Device Applications (PDF - 363KB) 
  Updated: 11/20/2009
• Complete List of Currently Approved Premarket Approvals (PMAs) (PDF - 28KB) 
  Updated: 11/20/2009
• Complete List of Currently Approved NDA and ANDA Application Submissions (PDF - 60KB) 
  Updated: 11/20/2009
• ALBAclone (Alba Bioscience Limited) 
  Posted: 11/19/2009
• December 15, 2009: Vaccines & Related Biological Products Advisory Committee Meeting Announcement 
  Posted: 11/19/2009
• Jobs at the Center for Biologics Evaluation and Research (CBER) 
  Mathematical Statistician, Posted: 11/19/2009
• Influenza A (H1N1) 2009 Monovalent Vaccines Composition and Lot Release 
  Lot release information, Updated: 11/18/2009
• Influenza Virus Vaccine for the 2009-2010 Season 
  Lot release information, Updated: 11/18/2009
• Complete List of Licensed Products and Establishments 
  Information Updated through October 31, 2009, Updated: 11/18/2009
• Gardasil 
  Statistical and Clinical Reviews for 10/16/2009 approval of new indication, Posted: 11/17/2009
• Jobs at the Center for Biologics Evaluation and Research (CBER) 
  Research Biologist (OVRR/DBPAP/LRSP), Posted: 11/17/2009
• November 18-19, 2009: Vaccines and Related Biological Products Advisory Committee Briefing Documents 
  Briefing documents posted for November 19, 2009 meeting, Updated: 11/17/2009
• November 18-19, 2009: Vaccines and Related Biological Products Advisory Committee Briefing Documents 
  Briefing documents posted for November 18, 2009 meeting, Updated: 11/16/2009
• Jobs at the Center for Biologics Evaluation and Research (CBER) 
  Consumer Safety Officer (OCOD/DDOM/EDT), Updated: 11/16/2009
• Influenza A (H1N1) 2009 Monovalent Vaccines Descriptions and Ingredients 
  Updated: 11/16/2009
• Jobs at the Center for Biologics Evaluation and Research (CBER) 
  Biostatistics Fellowship (OBE), Posted: 11/13/2009
• SOPP 8007: DCC Binding Procedures for Regulatory Documents 
  Updated: 11/13/2009
• Platelet PGD Test System (2009) 
  Substantially Equivalent 510(k) submission, Posted: 11/13/09
• Public Workshop: FDA Regulation and Licensure of Whole Blood and Blood Components 
  Updated: 11/13/2009
• Draft Guidance for Industry: Recommendations for the Assessment of Blood Donor Suitability, Blood Product Safety, and Preservation of the Blood Supply in Response to Pandemic (H1N1) 2009 Virus (PDF - 80KB) 
  Posted: 11/13/2009
• Cervarix 
  Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant, Posted: 11/13/2009
• Jobs at the Center for Biologics Evaluation and Research (CBER) 
  Consumer Safety Officer (OCOD/DDOM/EDT), Posted: 11/12/2009
• November 16-17, 2009: Blood Products Advisory Committee Meeting Materials 
  Updated: 11/12/2009
• Influenza A (H1N1) 2009 Monovalent Vaccine (ID Biomedical Corporation of Quebec) 
  Posted: 11/10/2009
• Influenza A (H1N1) 2009 Monovalent Vaccine (CSL Limited) 
  Expanded age of administration, Posted: 11/10/2009
• AFLURIA 
  Expanded age of administration, Posted: 11/10/2009
• Influenza A (H1N1) 2009 Monovalent Vaccines Composition and Lot Release 
  Lot release information, Updated: 11/10/2009
• Influenza Virus Vaccine for the 2009-2010 Season 
  Lot release information, Updated 11/10/2009
• November 16-17, 2009: Blood Products Advisory Committee Meeting Materials 
  Updated: 11/9/2009
• Guidance for Industry: Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Donors of Whole Blood and Blood Components Intended for Transfusion (PDF - 68KB) 
  Posted: 11/6/2009
• Jobs at the Center for Biologics Evaluation and Research (CBER) 
  Postdoctoral Fellowship (OVRR/DBPAP/LRP), Updated: 11/6/2009
• Berinert 
  C1 Esterase Inhibitor (Human)-Approval History,Letters, Reviews and Related Documents, Posted: 11/6/2009
• Important Registration and Listing Reminder for Manufacturers of Biological Drug Products Subject to 21 C.F.R. Part 207 
  Posted: 11/4/2009
• 2009 Meeting Materials of the Blood Products Advisory Committee 
  Briefing Documents for the November 16-17, 2009 Meeting of the Blood Products Advisory Committee, Posted 11/4/2009
• Influenza A (H1N1) 2009 Monovalent Vaccines Composition and Lot Release 
  Lot Release Information, Updated: 11/4/2009
• Influenza Virus Vaccine for the 2009-2010 Season 
  Lot Release Information, Updated: 11/4/2009
• ProQuad 
  Approval Letter and Approved Final Draft Labeling for Merck's Efficacy Supplement for Measles, Mumps, Rubella, and Varicella Vaccine, Live, (ProQuad)
• 2009 Meeting Materials, Vaccines and Related Biological Products Advisory Committee 
  Waivers for Conflicts of Interest for the November 18-19, 2009 Vaccines and Related Biological Products Advisory Committee Meeting, Posted 11/3/2009
• 2009 Meeting Materials of the Blood Products Advisory Committee 
  Waivers for Conflicts of Interest for the November 16-17, 2009 Blood Products Advisory Committee Meeting, Posted 11/2/2009
• Urgent Medical Device Removal: COBAS AmpliPrep/COBAS Amplicor HIV-1 Monitor Test 
  Posted: 10/29/2009
• Jobs at the Center for Biologics Evaluation and Research (CBER) 
  Research Technician (OVRR/DBPAP/LMDCI), Posted 10/28/2009
• Jobs at the Center for Biologics Evaluation and Research (CBER) 
  Postdoctoral Fellowship (OVRR/DBPAP/LMDCI), Posted 10/28/2009
• Influenza A (H1N1) 2009 Monovalent Vaccines Composition and Lot Release 
  Lot Release Information, Updated: 10/28/2009
• Influenza Virus Vaccine for the 2009-2010 Season 
  Lot Release Information, Updated: 10/28/2009
• Use of Influenza A (H1N1) 2009 Monovalent Influenza Vaccine in Pregnant Women 
  Posted: 10/27/2009
• Ixiaro 
  Japanese Encephalitis Vaccine, Inactivated, Adsorbed, Posted: 10/27/2009
• Public Workshop: Emerging Arboviruses: Risk Assessment for Blood, Cell, Tissue and Organ Safety 
  Dec 14 - 15, 2009 Public Workshop, Posted: 10/27/2009
• Regulatory Affairs Professionals Society (RAPS) Annual Conference and Exhibition 
  Sept 13 - 16, Presentation Posted: 10/26/2009
• Common Ingredients in U.S. Licensed Vaccines 
  Posted: 10/23/2009
• Human Cell, Tissues and Cellular and Tissue-Based Products (HCT/P) List of Registered Establishments 
  Updated: 10/23/2009