Pediatric Advisory Subcommittee of the Anti-Infective Drugs Advisory Committee
Food and Drug Administration
Center for Drug Evaluation and Research
Hilton, The Ballrooms, 620 Perry Parkway, Gaithersburg, MD.
Draft Agenda for October 30, 2003
8:00 Call to Order, Introductions: Joan P. Chesney, M.D., Chair
Meeting Statement: Thomas H. Perez, R.Ph., M.P.H.
Opening Comments: Dianne Murphy, M.D.
Director, Office of Counter-terrorism and Pediatric Drug Development
Jonathan Wilkin, M.D.
Director, Division of Dermatologic
and Dental Drug Products
8:30 Review of Topical Calcineurin Inhibitors Bindi Nikhar, M.D.
Division of Dermatologic and
Dental Drug Pruducts
8:50 Topical Immunosuppressants (Calcineurin Barbara Hill, Ph.D.
Inhibitors) - Animal Toxicology Division of Dermatologic and
Dental Drug Products
9:20 Post Marketing Adverse Event Reports ODS Staff
9:30 Q&A for Presenters
10:00 Studying the Risk of Cancer with Topical Lois La Grenade, M.D.
10:50 Practical and Methodological Issues in Elizabeth Andrews, Ph.D.
Long Term Follow-up Studies RTI Health Solutions
11:20 The Role of Cancer Registries in Long Term Phyllis Wingo, Ph.D.
Follow-up Studies Centers for Disease Control
Cancer Registry Program
11:50 Q&A for Presenters
1:00 Open Public Hearing
2:00 Discussion of Questions 1 & 2
3:30 Wrap up and adjourn