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.

Tracking Cancer Risk among Children with Atopic Dermatitis

who are Treated with Topical Calcineurin Inhibitors

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.

Executive Secretary

Opening Comments: Dianne Murphy, M.D.

Director, Office of Counter-terrorism and Pediatric Drug Development

and

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

9:45 Break

10:00 Studying the Risk of Cancer with Topical Lois La Grenade, M.D.

Calcineurin Inhibitor Use in Children: Design Issues Office of Drug Safety

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

12:00 Lunch

1:00 Open Public Hearing

2:00 Discussion of Questions 1 & 2

3:30 Wrap up and adjourn