Food and Drug Administration, Center for Biologics Evaluation and Research

Vaccines and Related Biological Products Advisory Committee Meeting

May 16 - 17, 2007

Hilton Hotel, Washington DC North/Gaithersburg

620 Perry Parkway, Gaithersburg, MD 20877

DRAFT AGENDA

 

Day 1 – May 16, 2007

Open Session

8:30 a.m.         Call to Order and Opening Remarks              John Modlin, M.D., Acting Chair

8:35                 Administrative Matters                                   Christine Walsh, R.N., FDA

 

Topic 1: Safety and Effectiveness of FluMist™ in a Pediatric Population Less Than 59 Months of Age 

 

8:45 a.m.         Introduction/Background                               Douglas Pratt, M.D., FDA

 

8:55                 MedImmune Presentation                               MedImmune  

                                                                                                           

9:55                 Questions/Clarifications

 

10:05               Break

 

10:15               FDA Presentation                                           Therese Cvetkovich, M.D., FDA

                                                                                                Melisse Baylor, M.D., FDA

                                                                                                Sang Ahnn, Ph.D., FDA

 

11:15               Questions/Clarifications

 

11:25               Open Public Hearing

 

11:55               Committee Discussion and Recommendations

 

1:15 p.m.         Lunch

 

Committee Update: Influenza Strain Selection for the 2007 – 2008 Influenza Season

 

2:30 p.m.         Influenza Strain Selection Update                  CDC

 

Topic 2:  Overview of Laboratory of Bacterial Polysaccharides/Laboratory of Enteric & Sexually Transmitted Diseases, Division of Bacterial Parasitic & Allergenic Products, Office of Vaccines Research and Review, CBER

 

2:45 p.m.         Overview of Laboratory of Bacterial                         Willie Vann, Ph.D., FDA

                            Polysaccharides

 

3:05                 Questions/Clarifications

 

3:10                 Overview of Laboratory of Enteric &            Dennis Kopecko, Ph.D., FDA

                            Sexually Transmitted Diseases

 

3:30                 Questions/Clarifications

 

3:35                 Open Public Hearing

 

4:05                 Closed Session

 

4:45                 Adjourn for day