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