Food And Drug Administration
Center For Biologics Evaluation And Research
Vaccines And Related Biological Products Advisory Committee Meeting
AGENDA
8:30 a.m. Call to Order Dr. Gary Overturf, Chair
8:35 Administrative Matters Christine Walsh R.N., FDA
Influenza Virus for the 2005 – 2006 Season
8:45 Introduction Dr. Roland Levandowski, FDA
9:45 U.S. Surveillance Dr. Keiji Fukuda, CDC
10:15 Break
10:30 World
Surveillance and Strain Dr. Nancy Cox, CDC
Characterization
11:00 Additional Reports Linda Canas, DOD
12:00 Lunch
1:00 Open Public Hearing
1:30 Vaccine Responses Dr. Roland Levandowski
2:00 Availability of Strain and Reagents Dr. Zhiping Ye, FDA
2:15 Comments
from Manufacturers Albert Thomas, sanofi pasteur
3:00 Break
3:15 Options for Strain Selection Dr. Roland Levandowski
3:30 Committee Discussion and Recommendation
5:00 Adjourn for the day
Food And Drug Administration
Center For Biologics Evaluation And Research
Vaccines And Related Biological Products Advisory Committee Meeting
AGENDA
8:30 a.m. Call to Order Dr. Gary Overturf, Chair
8:35 Announcements Christine Walsh, R.N.
8:45 Open Public Hearing
Session II – Open Committee
Discussion – FDA Critical Path Initiative Update
9:15 Presentation to Committee Dr. Mary Foulkes, FDA
Dr. Jerry Weir, FDA
9:45 Q&A
9:50 Break
Session III – Open Committee
Discussion – Committee Presentation;
Respiratory Viral Diseases
10:05 Overview – Laboratory of Biophysics Dr. Richard Walker, FDA/
Dr. Richard Pastor, FD
10:35 Q&A
10:45 Overview - Laboratory of Pediatrics & Dr. Jerry Weir, FDA
Respiratory Viral Diseases
11:15 Q&A
11:25 Break/Adjourn Open Session
1:00 Break/Adjourn Closed Session 1
1:05 Closed Session II