Food And Drug Administration

Center For Biologics Evaluation And Research

Vaccines And Related Biological Products Advisory Committee Meeting

Thursday, May 18, 2006

Hilton Hotel, Washington DC North/Gaithersburg,

620 Perry Parkway, Gaithersburg, MD 20877



Open Session

9:00 a.m.         Call to Order and Opening Remarks            Monica M. Farley, M.D., Acting Chair

9:05                 Administrative Matters                          Christine Walsh, R.N., FDA


Safety and Efficacy of GARDASIL® (Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine) Manufactured by Merck


9:20 a.m.          FDA Brief Introduction                                     Nancy Miller, M.D., FDA  

Presentation of Questions


9:30                 Sponsor Presentation                                        Eliav Barr, M.D./

Merck Research Laboratories               Patrick Brill-Edwards, M.D.


10:45               Break


11:00               FDA Presentation                                             Nancy Miller M.D., FDA


12 noon            Lunch


1:30 p.m.          Open Public Hearing


2:30                 FDA Presentation of Questions                         Nancy Miller, M.D., FDA


2:40                 Committee Discussion of FDA Questions

Committee Recommendations


4:45 p.m.          Adjourn meeting