Recently Added

• Potential “universal” influenza vaccine developed and tested at FDA
  Posted: 5/21/2013
• Approval History, Letters, Review, and Related Documents - Kcentra
  Posted: 5/21/2013
• May 17, 2013 Approval Letter - IXIARO
  Posted: 5/21/2013
• Public Workshop: Fecal Microbiota for Transplantation - Presentations
  Posted: 5/16/2013
• Summary Basis for Regulatory Action, April 19, 2013 - SOLX® System
  Posted: 5/16/2013
• A mouse model demonstrates a link between transfused UVB irradiated platelets and acute lung injury
  Posted: 5/16/2013
• Postdoctoral Fellowship (OVRR)
  Posted: 5/14/2013
• 2013 Meeting Materials, Cellular, Tissue and Gene Therapies Advisory Committee
  Updated: 5/14/13- added 4/17/13 transcripts and summary minutes
• 2013 Advisory Committee Tentative Meetings
  Updated: 5/14/13
• BK120084 Phlebotomy System 1.0.0
  Posted: 5/10/2013
• RegenKit®-THT-Untitled Letter
  Posted: 5/9/2013
• 7342.007 - Imported CBER-Regulated Products
  Updated: 5/9/2013
• Guidance for Industry: Implementation of an Acceptable Abbreviated Donor History Questionnaire and Accompanying Materials for Use in Screening Frequent Donors of Blood and Blood Components
  Posted: 5/8/2013
• AABB Donor History Questionnaire Documents
  Posted: 5/8/2013
• FDA discovery that Ad5 vector uses coagulation factor X to block complement proteins has major implications for gene therapy (PDF - 182KB)
  Posted: 5/7/2013
• Expanded and improved approach to identifying surface protein markers could support development of therapies with human bone marrow multipotent stromal cells (PDF - 262KB)
  Posted: 5/7/2013
• List of Establishments Granted Approval for a Variance to 21CFR640.3(d) and 21CFR640.3(f)
  Posted: 5/6/2013
• Field Correction - ALBAcyte Antibody Screening Cells
  Posted: 5/3/2013
• Public Workshop: Application of Advances in Nucleic Acid and Protein-Based Detection Methods for Multiplex Detection of Transfusion-Transmissible Agents and Blood Cell Antigens in Blood Donations Transcripts - April 10, 2013 (PDF - 5.3MB)
  Posted: 5/2/2013
• Public Workshop: Application of Advances in Nucleic Acid and Protein-Based Detection Methods for Multiplex Detection of Transfusion-Transmissible Agents and Blood Cell Antigens in Blood Donations Transcripts - April 11, 2013 (PDF - 6.1MB)
  Posted: 5/2/2013
• Urgent Product Recall - Anticoagulant Citrate Phosphate Dextrose Solution, USP (CPD) BLOOD-PACK Unit
  Posted: 4/30/2013
• Urgent - Medical Device Recall - Trima Accel Automated Blood Collection System
  Posted: 4/30/2013
• Kcentra (Prothrombin Complex Concentrate, Human)
  Approval Letter and Product Labeling, Posted: 4/30/2013
• SOLX® System
  Posted: 4/26/2013
• FDA study reinforces no safety concerns from residual formaldehyde in some infant vaccines
  Posted: 4/25/2013
• HEMACORD (HPC, cord blood)
  Approval Letter and Package Insert, Posted: 4/25/2013
• Biologic Product Shortages
  Updated: 4/25/2013
• Urgent Biological Product Notification Seraclone Anti-S
  Posted: 4/25/2013