Food And Drug Administration

Center For Biologics Evaluation And Research

Vaccines And Related Biological Products Advisory Committee Meeting

March 15, 2005

Holiday Inn Select, 8120 Wisconsin Ave., Bethesda, MD 20814

 

DRAFT AGENDA

 

8:30 a.m. Call to Order Gary Overturf, M.D., Chair

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

 

Session 1 Open Committee Discussion Safety and Immunogenicity for Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed (Tdap) manufactured by GlaxoSmithKline Biologicals

 

8:45 Tdap Introduction/Background/ Theresa Finn, Ph.D., FDA

Presentation of Questions

 

9:00 Clarifications/Questions

 

9:05 GSK/Tdap/Boostrix GlaxoSmithKline

 

10:05 Clarifications/Questions

 

10:15 Break

 

10:30 FDA Presentation Ann Schwartz, M.D., FDA

 

11:00 Clarifications/Questions

 

11:10 Open Public Hearing

 

11:40 Committee Discussion and Recommendations

 

12:40 p.m. Lunch

 

Session ll Open Committee Discussion Safety and Immunogenicity data for Tdap

vaccine manufactured by Aventis Pasteur Ltd

 

1:45 Adacel Introduction Martha Monser, B.A., FDA

 

1:55 AP Tdap/Adacel Aventis Pasteur, Ltd.

 

2:55 Clarifications/Questions

Food And Drug Administration

Center For Biologics Evaluation And Research

Vaccines And Related Biological Products Advisory Committee Meeting

March 15, 2005

Holiday Inn Select, 8120 Wisconsin Ave., Bethesda, MD 20814

 

DRAFT AGENDA

 

 

3:05 Break

 

3:20 FDA Presentation Chris Mink, M.D., FDA

 

4:00 Clarifications/Questions

 

4:10 Open Public Hearing

 

4:40 Committee Discussion and Recommendation

 

5:40 Adjourn Meeting