Pediatric Advisory Committee


Food and Drug Administration

ACS Conference Room, Room 1066

5630 Fishers Lane, Rockville, Maryland 20857


Agenda for September 15, 2004

8:00-2:00 pm



8:00      Call to Order, Introductions                          Chair, Pediatric Advisory Committee


            Meeting Statement                                         Jan Johannessen, PhD

                                                                                    Executive Secretary




8:20            Subpart D Referral Process                                   Sara F. Goldkind, MD, MA

Bioethicist, Office of Pediatric Therapeutics



8:25            Summary of Deliberations of Pediatric            Chair, Pediatric Ethics Subcommittee

Ethics Subcommittee held on 9-10-04                               




9:10            Overview of Adverse Event Reporting as            Solomon Iyasu, MD

Mandated by BPCA            Medical Epidemiologist,

Office of Pediatric Therapeutics



9:25            Adverse Event Reporting


Ocuflox (ofloxacin)                                Hari Sachs, MD

Fosamax (alendronate)                             Medical Officer

                                                            Division of Pediatric Drug Development


Fludara (fludarabine)                             Susan McCune, MD

                                                            Medical Officer

                                                            Division of Pediatric Drug Development



Clarinex (desloratadine)                          Jane Filie, MD

                                                            Medical Officer

                                                            Division of Pediatric Drug Development


10:25    Break             


10:40            Adverse Event Reporting for Drug Products Containing Budesonide or Fluticasone:

Pulmicort, Rhinocort, Flonase, Flovent, Advair, and Cutivate


                                                                                    Peter Starke, MD

                                                                                    Medical Team Leader

                                                                                    Division of Pulmonary Drug Products



Joyce Weaver, Pharm. D.

                                                                                    Safety Evaluator

                                                                                    Division of Drug Risk Evaluation


11:30    Open Public Hearing


12:30    Final Comments and Adjourn