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


                                                                                                                                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