Recently Added

• Twinrix 
  Package Insert, Approval Letter, Posted: 9/10/2010
• ProQuad 
  Package Inserts, Approval Letter, Posted: 9/10/2010
• Complete List of Licensed Products and Establishments 
  Posted: 9/10/2010
• July 26, 2010: Meeting of the Blood Products Advisory Committee Transcript (PDF - 388KB) 
  Posted: 9/9/2010
• July 27, 2010: Meeting of the Blood Products Advisory Committee Transcript (PDF - 172KB) 
  Posted: 9/9/2010
• Recall of Abbott Prism HIV O Plus 
  Posted: 9/9/2010
• Rotarix 
  Package Insert, Approval Letter, Posted: 9/8/2010
• RotaTeq 
  Package Insert, Patient Information, Approval Letter, Posted: 9/8/2010
• Influenza Virus Vaccine for the 2010-2011 Season 
  Updated: 9/8/2010
• Agenda for the Public Workshop on Cell and Gene Therapy Clinical Trials in Pediatric Populations 
  Posted: 9/8/2010
• Important Information Regarding Sanofi Pastuer’s Influenza A (H1N1) 2009 Monovalent Vaccine in Multidose Vials 
  Posted: 9/8/2010
• Program Support Specialist 
  IOD/OVRR, Posted: 9/8/2010
• Guidance for Industry: Bar Code Label Requirements - Questions and Answers (Question 12 Update) (PDF - 31KB) 
  Posted: 9/7/2010
• Public Meeting on Animal Models—Essential Elements to Address Efficacy Under the Animal Rule; and Reopening of Comment Period 
  Posted: 9/7/2010
• Dear Healthcare Provider Letter: Information Re: Havrix (Hepatitis A Vaccine) Tip Caps Of The Prefilled Syringes May Contain Natural Rubber Latex Which May Cause Allergic Reactions In Latex Sensitive Individuals 
  Posted: 9/7/2010
• Dear Healthcare Provider Letter: Information Re: Engerix-B (Hepatitis B Vaccine (Recombinant)) Tip Caps of the Prefilled Syringes May Contain Natural Rubber Latex Which May Cause Allergic Reactions in Latex Sensitive Individuals 
  Posted: 9/7/2010
• AFLURIA 
  August 30, 2010 clarification letter to the November 10, 2009 letter, regarding the pediatric study.
• Supervisory Medical Officer 
  GP-0602-14, Posted: 9/3/10
• August 26, 2010 Approval Letter - Infanrix 
  Approval Letter and Revised Package Insert, Posted: 9/2/2010
• Medical Officer – Adult or Pediatric Oncology 
  GP-602-14 plus physician market pay (Title 38), Posted: 9/2/2010
• Public Workshop on Cell and Gene Therapy Clinical Trials in Pediatric Populations 
  FR Notice posted, Updated: 9/2/2010
• 7341.002 - Inspection of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) 
  Updated: 9/1/2010
• Medical Officer 
  GP-0602-14, OD/OBE, Posted: 9/1/2010
• Interdisciplinary Scientist 
  GS-0403-14, OD/OBE, Posted: 9/1/2010
• Interdisciplinary Scientist 
  GS-0601-14, OD/OBE, Posted: 9/1/2010
• Interdisciplinary Scientist 
  GS-1529-14, OD/OBE, Posted: 9/1/2010
• Interdisciplinary Scientist 
  GS-0415-14, OD/OBE, Posted: 9/1/2010
• Interdisciplinary Scientist 
  GS-0401-14, OD/OBE, Posted: 9/1/2010
• Interdisciplinary Scientist 
  GS-0405-14, OD/OBE, Posted: 9/1/2010
• August 23, 2010 Approval Letter - Havrix 
  Posted: 8/31/2010
• August 23, 2010 Approval Letter - Engerix-B 
  Posted: 8/31/2010
• Waivers for Conflicts of Interest for the September 21, 2010 Vaccines and Related Biological Products Advisory Committee Meeting 
  Posted: 8/31/2010
• September 21, 2010: Vaccines and Related Biological Products Advisory Committee Meeting Draft Agenda 
  Posted: 8/31/2010
• September 21, 2010: Vaccines and Related Biological Products Advisory Committee Roster 
  Posted: 8/31/2010
• September 21, 2010: Vaccines and Related Biological Products Advisory Committee Temporary Voting Members 
  Posted: 8/31/2010
• 2010 Biological License Application Supplement Noteworthy Approvals 
  Updated: 8/30/2010
• 2010 Biological Device Application Approvals 
  Updated: 8/30/2010
• SOPP 8413: Postmarketing Commitment Related Submissions - Administrative Handling, Review, and CBER Reporting 
  Updated: 8/30/2010
• Supervisory Medical Officer 
  OVRR/DVP/LDV, Posted: 8/27/2010
• Fluvirin 
  Approval Letter and Package Insert, Posted: 8/26/2010
• Regulatory Information Specialist 
  OCOD/DCCA/CTB, Posted: 8/26/2010
• URGENT - Voluntary Market Withdrawal of Octagam [Immune Globulin Intravenous (human)] 5% Liquid Preparation 
  Posted: 8/24/2010
• Director, DBPAP 
  OVRR/DPAP, Posted: 8/24/2010
• Supervisory Mathematical Statistician 
  OBE, GS-1529-14, Posted: 8/20/2010
• Fluarix 
  July 19, 2010 clarification letter to the October 19, 2009 letter, regarding the pediatric study.
• SparVax (Recombinant Protective Antigen (rPA) Anthrax Vaccine) - Untitled Letter 
  Posted: 8/13/2010
• Complete List of Currently Approved NDA and ANDA Application Submissions (PDF - 62KB) 
  Updated: 8/12/2010
• Complete List of Currently Approved Premarket Approvals (PMAs) (PDF - 27KB) 
  Updated: 8/12/2010
• Complete List of Substantially Equivalent 510(k) Device Applications (PDF - 375KB) 
  Updated: 8/12/2010
• SOPP 8116: Using Electronic Signatures for Investigational and Marketing Regulatory Document Concurrence/Signoff 
  Updated: 8/12/2010