Advisory Committees
2012 Meeting Materials, Vaccines and Related Biological Products Advisory Committee
November 14-15, 2012
On November 14, 2012, the committee will meet in open session to discuss and make recommendations on the safety and immunogenicity of an Influenza A (H5N1) Virus Monovalent Vaccine manufactured by GlaxoSmithKline. On November 15, 2012, the committee will meet in open session to discuss and make recommendations on the safety and efficacy of a Hepatitis B Vaccine manufactured by Dynavax.
- Announcement
- Draft Agenda (PDF - 22KB)
- Draft Member Roster (PDF - 31KB)
Errata to the Dynavax Sponsor Package (PDF - 41KB)- Errata Topic II FDA Issue Summary Heplisav (PDF - 38KB)
FDA Briefing Document (PDF - 523KB)- Final Agenda (PDF - 28KB)
- Final Roster
GSK Sponsor Briefing Document Topic I (PDF - 1MB)
Persons with disabilities having problems accessing the PDF file may call 301-827-0314 for assistance.- Dynavax Sponsor Briefing Document Topic II (PDF - 1.7MB)
Persons with disabilities having problems accessing the PDF file may call 301-827-0314 for assistance. - November 14, 2012 Transcript (PDF - 460KB)
- November 15, 2012 Transcript (PDF - 350KB)
- November 14-15, 2012 Summary Minutes (PDF - 55KB)
- Presentations
- Topic 1: FDA Final Issue Summary (PDF - 328KB)
- Topic 1: FDA Issue Summary Errata (PDF - 32KB)
- Topic II FDA Issue Summary (PDF - 343KB)
Persons with disabilities having problems accessing the PDF file may call 301-827-0314 for assistance. - Waiver for Conflicts of Interest
- Webcast
September 19, 2012
On September 19, 2012, the committee will meet in open session to discuss consideration of the appropriateness of cell lines derived from human tumors for vaccine manufacture.
Draft Agenda (PDF - 26KB)Bibliography FDA Briefing Document; Cell Lines Derived from Human Tumors for Vaccine Manufacture FDA Briefing Document: Cell Lines Derived from Human Tumors for Vaccine Manufacture (PDF - 209KB)- Meeting Announcement
- Meeting Roster (PDF - 27KB)
September 19, 2012: Vaccines and Related Biological Products Advisory Committee Meeting: Presentations - Summary Minutes (PDF - 32KB)
- Transcript (PDF - 313KB)
- Waivers for Conflicts of Interest
- Webcasts
February 28-29, 2012
On February 28, 2012, the committee will hear an overview of the research program in the Laboratory of Mycobacterial Diseases and Cellular Immunology, Division of Bacterial, Parasitic and Allergenic Products, Office of Vaccines Research and Review, Center of Biologics Evaluation and Research, FDA....
- Briefing Document (PDF - 54KB)
- Draft Agenda (PDF - 29KB)
- February 28, 2012 Transcript (PDF - 317KB)
- February 29, 2012 Transcript (PDF - 254KB)
- Final Agenda (PDF - 23KB)
- Final Member Roster
Summary Minutes (PDF - 28KB)- Meeting Announcement
- Member Roster
- Presentations
- Waivers for Conflicts of Interest
- Webcasts
