What’s New for Biologics

What’s New for Biologics

Recently Added

• Roster of the Allergenic Products Advisory Committee¹
  Updated: 10/10/2012
  
• Influenza Virus Vaccine for the 2012-2013 Season²
  Updated: 10/10/2012
  
• Blood Grouping Reagent, Anti-K ALBAsera®³
  Alba Bioscience Limited, Posted: 10/9/2012
  
• Blood Grouping Reagent, Anti-Fy^a ALBAsera®⁴
  Alba Bioscience Limited, Posted: 10/9/2012
  
• Blood Grouping Reagent, Anti-Fy^b ALBAsera®⁵
  Alba Bioscience Limited, Posted: 10/9/2012
  
• Blood Grouping Reagents, Anti-Wr^a ALBAsera®⁶
  Alba Bioscience Limited, Posted: 10/9/2012
  
• Blood Grouping Reagent, Anti-s ALBAsera®⁷
  Alba Bioscience Limited, Posted: 10/9/2012
  
• Public Workshop: Use of Computer Simulation of the United States Blood Supply in support of Planning for Emergency Preparedness and Medical Countermeasures - Transcript (PDF - 263KB)⁸
  Posted: 10/5/2012
  
• Ducord, HPC Cord Blood⁹
  Hematopoietic Progenitor Cell, Posted: 10/5/2012
  
• Information for Blood Establishments: Unavailability of CHIRON® RIBA® HCV 3.0 SIA (RIBA)¹⁰
  Posted: 10/4/2012
  
• User Fee Billable Biologic Products and Potencies Approved Under Section 351 of the PHS Act¹¹
  Updated: 10/3/2012
  
• 2012 Meeting Materials, Vaccines and Related Biological Products Advisory Committee¹²
  September 19, 2012 Meeting Materials Updated: 10/3/2012
  
• Clinical Investigator Status (Biologics)¹³
  Updated: 10/3/2012
  
• Exceptions and Alternative Procedures Approved Under 21 CFR 640.120¹⁴
  Updated: 10/2/2012
  
• Recall of Thymoglobulin [Anti-thymocyte Globulin (Rabbit)] 25mg/vial¹⁵
  Posted: 8/28/2012
  
• September 26, 2012 Approval Letter - Boostrix¹⁶
  Posted: 10/1/2012
  
• Biological Product Deviation Reporting and HCT/P Deviation Reporting - Deviation Codes¹⁷
  Updated: 10/1/2012
  
• Important Product Information – Evicel and Evithrom¹⁸
  Posted: 10/1/2012
  
• 7342.008 - Inspection of Licensed In-Vitro Diagnostic (IVD) Devices Regulated by CBER¹⁹
  Updated: 10/1/2012
  
• Public Workshop: Risks and Benefits of Hydroxyethyl Starch Solutions - September 7, 2012 Transcript (PDF - 359KB)²⁰
  Posted: 9/28/2012
  
• Public Workshop: Risks and Benefits of Hydroxyethyl Starch Solutions - September 6, 2012 Transcript (PDF - 800KB)²¹
  Posted: 9/28/2012
  
• Recall of Typhim Vi, Typhoid Vi Polysaccharide Vaccine²²
  Posted: 9/28/2012
  
• BK120036 - HCLL™ Transfusion²³
  Posted: 9/28/2012
  
• Influenza Virus Vaccine for the 2012-2013 Season²⁴
  Updated: 9/27/2012
  
• BK120039 - LifeTrak Version 2012²⁵
  Posted: 9/25/2012
  
• Biological Product Deviation Reporting and HCT/P Deviation Reporting - Non-Blood Product Codes²⁶
  Updated: 9/25/2012
  
• Final Guidance for Industry: Pre-Storage Leukocyte Reduction of Whole Blood and Blood Components Intended for Transfusion.²⁷
  Posted: 9/25/2012
  
• 2012 Biological License Application Supplement Approvals²⁸
  Posted: 9/21/2012
  
• 2012 Biological Device Application Approvals²⁹
  Posted: 9/21/2012
  
• BK110071 - TSCD®II Sterile Tubing Welder with or without Trucise® Total System³⁰
  Posted: 9/21/2012
  
• Influenza Virus Vaccine for the 2012-2013 Season³¹
  Updated: 9/19/2012
  
• FDA Basics – OCTGT Webinar on Tissue Safety³²
  Posted: 9/19/2012
  
• September 20-21, 2012: 2012 Meeting Materials, Blood Products Advisory Committee: Octapharma Issue Summary (PDF - 231KB)³³
  Persons with disabilities having problems accessing the PDF may call 301-827-0314 for assistance.; Posted: 9/18/2012
  
• September 20-21, 2012: 2012 Meeting Materials, Blood Products Advisory Committee: Topic 2 Issue Summary (PDF - 537KB)³⁴
  Posted: 9/18/2012
  
• Supporting the Development of Mesenchymal Stem Cells as Medical Therapies³⁵
  Research Summary; Posted: 9/17/2012
  
• September 14, 2012 Approval Letter - Prevnar 13³⁶
  Approval Letter and Package Insert, Posted: 9/17/2012
  
• Developing Gene Therapy for Cancers Using Virus Vectors³⁷
  Research Summary; Posted: 9/17/2012
  
• September 14, 2012 Approval Letter - Imovax³⁸
  Approval Letter and Package Insert, Posted: 9/17/2012
  
• September 19, 2012: Vaccines and Related Biological Products Advisory Committee: FDA Briefing Document: Cell Lines Derived from Human Tumors for Vaccine Manufacture (PDF - 209KB)³⁹
  Posted: 9/17/2012
  
• September 19, 2012: Vaccines and Related Biological Products Advisory Committee: Meeting Roster (PDF - 26KB)⁴⁰
  Posted: 9/15/2012
  
• September 19, 2012: Vaccines and Related Biological Products Advisory Committee: Draft Agenda (PDF - 26KB) (PDF - 26KB)⁴¹
  Posted: 9/15/2012
  
• September 19, 2012: Vaccines and Related Biological Products Advisory Committee: Meeting Roster (PDF - 26KB) (PDF - 27KB)⁴²
  Posted: 9/15/2012
  
• September 20-21, 2012: Blood Products Advisory Committee Meeting: Topic I: "Hepatitis E Virus (HEV) and Blood Transfusion Safety (PDF - 326KB)⁴³
  Posted: 9/14/2012
  
• September 20-21, 2012: Blood Products Advisory Committee Meeting: Topic 3: Issue Summary: "Considerations for Strategies to Further Reduce the Risk of Bacterial Contamination in Platelets" (PDF - 66KB)⁴⁴
  Posted: 9/14/2012
  
• September 20-21, 2012: Blood Products Advisory Committee Meeting: Draft Agenda (PDF - 23KB)⁴⁵
  Posted: 9/14/2012
  
• DoVac Elite 1.0
  Software, Blood Bank, Stand Alone⁴⁶
  Posted: 9/14/2012
  
• FDA Basics – OCTGT Webinar on Tissue Safety⁴⁷
  Posted: 9/12/2012
  
• Update: Information on Rotarix - Labeling Revision Pertaining to Intussusception⁴⁸
  Posted: 9/7/2012
  
• September 7, 2012 Approval Letter - Rotarix⁴⁹
  Posted: 9/7/2012
  
• Influenza Virus Vaccine for the 2012-2013 Season⁵⁰
  Updated: 9/12/2012
  
• September 10, 2012 Approval Letter - Boostrix⁵¹
  Posted: 9/11/2012
  
• 2012 Meeting Materials, Vaccines and Related Biological Products Advisory Committee⁵²
  
• September 20-21, 2012 Blood Products Advisory Committee Meeting: Waivers for Conflicts of Interest⁵³
  Posted: 9/4/2012
  
• Impact of Severe Weather Conditions on Biological Products⁵⁴
  Updated: 8/30/2012
  
• Influenza Virus Vaccine for the 2012-2013 Season⁵⁵
  Updated: 8/29/2012