Advisory Committees
2012 Meeting Materials, Blood Products Advisory Committee
December 4-5, 2012
On December 4, 2012, the Committee will meet in open session to discuss labeling of Red Blood Cells with historical antigen typing results. On December 5, 2012, the Committee will meet in open session to discuss performance data considerations for infectious disease assays used to screen organ donors.
- Announcement
- Briefing Document (PDF - 153KB)
Draft Agenda - Day 1 (PDF - 34KB)- Draft Agenda - Day 2 (PDF - 34KB)
- Errata – FDA Briefing Document
- Final Agenda (PDF - 30KB)
- Roster
Topic I: Labeling of Red Blood Cell Units with Historical Antigen Typing Results (PDF - 99KB)Topic I: Labeling of Red Blood Cell Units with Historical Antigen Type Results Reference Document (PDF - 31KB)- Transcripts
- Webcasts
September 20-21, 2012
On September 20, 2012, the committee will discuss hepatitis E virus and blood transfusion safety. In the afternoon, the committee will discuss Octapharma’s biologics license application for Pooled Plasma (Human, Solvent/Detergent Treated). On September 21, 2012, the committee will discuss considerations for strategies to further reduce the risk of bacterial contamination in Platelets.
- Announcement
Draft Agenda (PDF - 23KB)- Member Roster (PDF - 53KB)
- September 20, 2012 Transcript (PDF - 349KB)
- September 21, 2012 Transcript (PDF - 311KB)
Octapharma Issue Summary (PDF - 231KB)
Persons with disabilities having problems accessing the PDF may call 301-827-0314 for assistance.- Presentations
- Summary Minutes (PDF - 95KB)
Topic I: "Hepatitis E Virus (HEV) and Blood Transfusion Safety (PDF - 326KB)Topic 2 Issue Summary (PDF - 537KB)Topic 3: Issue Summary: "Considerations for Strategies to Further Reduce the Risk of Bacterial Contamination in Platelets" (PDF - 66KB)- Waivers for Conflicts of Interest
Webcasts
June 12, 2012
On June 12, 2012 from 12 p.m. to approximately 3:45 p.m., the Committee will meet, by teleconference, in open session, to hear updates on the research programs of the Laboratory of Emerging Pathogens and the Laboratory of Bacterial and Transmissible Spongiform Encephalopathy Agents, Division of Emerging and Transfusion Transmitted Diseases, Office of Blood Research and Review, Center for Biologics Evaluation and Research, FDA....
May 15-16, 2012
On May 15, 2012, the committee will discuss as a device panel the evaluation of the safety and effectiveness of the OraQuick In-Home HIV Test....
- Announcement
Draft Agenda (PDF - 21KB)Issue Summary (PDF - 194KB)Topic: Evaluation of Potential New Plasma Products Manufactured Following Storage at Room Temperature for up to 24 Hours (PDF - 296KB)Member Roster (PDF - 75KB)OraQuick® In-Home HIV Test Sponsor Briefing Document (PDF - 397KB)
Persons with disabilities having problems accessing the PowerPoint file may call 301-827-0314 for assistance.Questions for the Committee (PDF - 17KB)References (PDF - 24KB)Transcript for May 15, 2012 (PDF - 319KB)Transcript for May 16, 2012 (PDF - 259KB)- Waivers for Conflicts of Interest
- Webcasts







