Recently Added

• Waivers for Conflicts of Interest for the February 22, 2010 Vaccines and Related Biological Products Advisory Committee Meeting 
  There are no Waivers for Conflicts of Interest, Posted: 2/5/2010
• Recall: Y-Type Blood Solution Sets 
  Baxter, Posted: 2/5/2010
• Complete List of Licensed Products and Establishments 
  Updated: 2/4/2010
• Biologic Product Shortages 
  Updated PedvaxHIB & Comvax information; Updated: 2/4/2010
• Jobs at the Center for Biologics Evaluation and Research (CBER) 
  Postdoctoral Fellowship, OBRR/DH/LBVB, Posted: 2/3/2010
• Complete List of Substantially Equivalent 510(k) Device Applications (PDF - 796KB) 
  Updated: 2/3/2010
• Complete List of Currently Approved NDA and ANDA Application Submissions (PDF - 171KB) 
  Updated: 2/3/2010
• Complete List of Currently Approved Premarket Approvals (PMAs) (PDF - 36KB) 
  Updated: 2/3/2010
• Black Widow Spider Antivenin (Equine) 
  Added Package Insert to product page, Posted: 2/3/2010
• Atgam 
  Added Package Insert to product page, Posted: 2/3/2010
• Influenza A (H1N1) 2009 Monovalent Vaccines Composition and Lot Release 
  Lot Release Information, Updated: 2/2/2010
• Botulism Antitoxin Bivalent (Equine) Types A and B 
  Added Package Insert to product page, Posted: 2/2/2010
• Vaccinia Immune Globulin Intravenous (Human) 
  Revised Package Inserts, Updated: 2/1/2010
• Influenza Virus Vaccine Actions 
  Updated: 1/29/2010
• 2009 Meeting Materials, Vaccines and Related Biological Products Advisory Committee 
  December 15, 2009 Meeting Transcript, Posted: 1/29/2010
• Jobs at the Center for Biologics Evaluation and Research (CBER) 
  Program Support Specialist, OVRR/DVRPA, Updated: 1/29/2010
• Jobs at the Center for Biologics Evaluation and Research (CBER) 
  Pharmacist /Lead /Supv Pharmacist, Direct Hire, Posted: 1/29/2010
• Jobs at the Center for Biologics Evaluation and Research (CBER) 
  Medical Officer/Lead /Supv Med Officer, Direct Hire, Posted: 1/29/2010
• Jobs at the Center for Biologics Evaluation and Research (CBER) 
  Veterinary Medical Officer/Lead/Supervisory, Direct Hire, Posted: 1/29/2010
• Cord Blood Licensure: A Workshop 
  Posted: 1/27/2010
• Influenza A (H1N1) 2009 Monovalent Vaccines Composition and Lot Release 
  Lot Release Information, Updated: 1/27/2010
• Flebogamma DIF 5% 
  Updated Package Insert. Updated: 1/26/2010
• WinRho SDF Liquid 
  Updated Package Insert, Patient Information, "Dear Healthcare Provider" Letter with Drug Warning Information. Updated: 1/26/2010
• Blood Establishment Computer Software: Understanding What to Include in a 510(k) Submission; Public Workshop 
  Transcripts Posted, Updated: 1/26/2010
• Jobs at the Center for Biologics Evaluation and Research (CBER) 
  Program Support Specialist, OVRR/DVRPA, Posted: 1/26/2010
• Public Workshop: Emerging Arboviruses: Evaluating the Threat to Transfusion and Transplantation Safety 
  Transcripts Posted, Updated: 1/22/2010
• Influenza Virus Vaccine for the 2009-2010 Season 
  Lot release information, Updated: 1/20/2010
• Influenza A (H1N1) 2009 Monovalent Vaccines Composition and Lot Release 
  Lot release information, Updated: 1/20/2010
• November 18-19, 2009: Vaccines and Related Biological Products Advisory Committee Briefing Documents 
  Presentations and Transcripts Posted, Updated: 1/20/2010
• Field Correction of Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal Expiration Dating 
  Posted: 1/15/2010
• 2010 Advisory Committee Tentative Meetings 
  Meeting Cancelled: April 30, 2010, Allergenic Products Advisory Committee, Posted: 1/15/2010
• February 22, 2010: Meeting of the Vaccines and Related Biological Products Advisory Committee 
  Meeting Announcement, Posted: January 15, 2010
• Influenza Virus Vaccine Actions 
  Updated: 1/14/2010
• Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal Questions and Answers 
  Posted: 1/13/2010
• Influenza A (H1N1) 2009 Monovalent Vaccines Composition and Lot Release 
  Lot release information, Updated: 1/13/2010
• Influenza Virus Vaccine for the 2009-2010 Season 
  Lot release information, Updated: 1/13/2010
• Fast Track Designation Request Performance 
  Updated: 1/12/2010
• Jobs at the Center for Biologics Evaluation and Research (CBER) 
  Chemist, OVRR/DPQ/PQLS, Posted: 1/12/2010
• Pentacel 
  12/22/2009 Approval Letter, updated Package Insert to revise labeling to comply with Physician's Labeling Rule format, Updated: 1/11/2010
• Clinical Investigator Status (Biologics) 
  Clinical Investigator Inspection List, Updated: 1/11/2010
• InterSol Solution/Platelet Additive Solution 3 
  Approval History, Letters, Reviews, and Related Documents, Updated: 1/8/2010
• Jobs at the Center for Biologics Evaluation and Research (CBER) 
  Interdisciplinary Scientist (Microbiologist), OVRR/DVRPA, Updated: 1/8/2010
• Jobs at the Center for Biologics Evaluation and Research (CBER) 
  Interdisciplinary Scientist (Chemist), OVRR/DVRPA, Updated: 1/8/2010
• Jobs at the Center for Biologics Evaluation and Research (CBER) 
  Interdisciplinary Scientist (Biologist), OVRR/DVRPA, Updated: 1/8/2010
• Complete List of Currently Approved NDA and ANDA Application Submissions (PDF - 171KB) 
  Updated: 1/8/2010
• Complete List of Currently Approved Premarket Approvals (PMAs) (PDF - 36KB) 
  Updated: 1/8/2010
• Complete List of Substantially Equivalent 510(k) Device Applications (PDF - 796KB) 
  Updated: 1/8/2010
• ROTARIX 
  12/30/2009 Approval Letter, Package Insert and Patient Information updated.
  Posted 1/7/2010
• Recall: Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal 
  MedImmune LLC, Posted: 1/7/2010
• Influenza A (H1N1) 2009 Monovalent Vaccines Composition and Lot Release 
  Lot release information, Updated: 1/6/2010
• Influenza Virus Vaccine for the 2009-2010 Season 
  Lot release information, Updated: 1/6/2010
• Jobs at the Center for Biologics Evaluation and Research (CBER) 
  Contract Specialist (Direct Hire), Various centers, Posted: 1/6/2010