FOOD AND DRUG ADMINISTRATION
Center for Drug Evaluation and Research
ANTIVIRAL DRUGS ADVISORY COMMITTEE MEETING
SUBCOMMITTEE FOR IMMUNOSUPPRESSANTS
TENTATIVE AGENDA
January 24, 2002
Gaithersburg Holiday Inn
Two Montgomery Village Avenue
Gaithersburg, MD 20879
NDA 21-083 Rapamune® (sirolimus) Oral Solution – Maintenance Regimen
8:30 a.m. Call to Order and Opening Remarks Chair, AVAC,
Subcommittee for Immunosuppressants
Introduction of Committee
Conflict of Interest Statement Tara P. Turner, Pharm. D.
Executive Secretary, AVAC
8:40 a.m. FDA Introductory Remarks Renata Albrecht, M.D.
Acting Director
Division of Special Pathogen
and Immunologic Drug
Products, FDA
8:45 a.m. Sponsor Presentation
10:45 a.m. Break
11:00 a.m. FDA Presentation Rosemary Tiernan, M.D., M.P.H.
Medical Officer
Division of Special Pathogen
and Immunologic Drug
Products, FDA
(Tentative Speaker)
12:00 p.m. Lunch
1:00 p.m. Open Public Hearing
2:00 p.m. Charge to the Committee Renata Albrecht, M.D.
Acting Director
Division of Special Pathogen
and Immunologic Drug
Products, FDA
2:10 p.m. Committee Discussion and Vote
5:00 p.m. Adjourn