Food and Drug
Administration
Center for Biologics
Evaluation and Research
Vaccines and Related
Biological Products Advisory Committee Meeting
November
14, 2007
National
Institutes of Health
Building
29B/Conference Room A/B
AGENDA
1:00 p.m. Call to Order Ruth A. Karron, M.D., Chair
Administrative Matters Christine Walsh R.N., FDA
Open Session –
Presentation of Laboratory of Method Development, Division of Viral Products; Laboratory
of Mycobacterial Diseases & Cellular Immunology, Division of Bacterial
Parasitic & Allergenic Products, Office of Vaccines Research and Review
1:10 Overview of Research/Site Visit Process, Michael Brennan, Ph.D., FDA
Center Biologics Evaluation and Research (CBER)
1:15 Overview Office of Vaccines Research Michael Brennan, Ph.D., FDA
and Review (OVRR), CBER
1:20 Overview Division of Viral Products (DVP), Jerry Weir, Ph.D., FDA
OVRR
1:25 Overview Laboratory of Method Konstantin Chumakov, Ph.D., FDA
Development, DVP
1:50 Q&A
1:55 Overview Division of Bacterial Parasitic &
Allergenic Products (DBPAP), OVRR
2:00 Overview Laboratory of Mycobacterial Sheldon Morris, Ph.D., FDA
Diseases & Cellular Immunology, DBPAP
2:25 Q&A
2:30 Open Public Hearing (if no speakers, will move directly to closed session)
3:30 Closed Session
4:30 Adjourn Meeting