Pediatric Advisory Subcommittee of the Anti-Infective Drugs Advisory Committee

 

Food and Drug Administration

Center for Drug Evaluation and Research

ACS Conference Room, Room 1066, 5630 Fishers Lane, Rockville, MD

 

Draft Agenda for February 3, 2004

 

Section 17, Best Pharmaceuticals for Children Act, Adverse Event Reporting

 

9:00       Call to Order, Introductions:                                                   Joan P. Chesney, M.D., Chair

 

               Meeting Statement:                                                                     Thomas H. Perez, M.P.H.

Executive Secretary

 

9:15       Adverse Event Reports per Section 17 of BPCA                   Solomon Iyasu, M.D.

                                                                                                                        Lead Medical Officer

                                                                                                                        Division of Pediatric

Drug Development

           

9:45       Open Public Hearing

 

10:15     Break

 

Use of Imaging Drugs  in Conjunction with

Cardiac Imaging Procedures in the Pediatric Population

 

10:30     Pediatric Regulatory Update                                                    Dianne Murphy, M.D.

Director, Office of Counter-terrorism and Pediatric Drug Development

 

10:45     FDA Perspective                                                                                         Sally Loewke, M.D.

                                                                                                                        Acting Director

                                                                                                                        Division of Medical Imaging and

                                                                                                                        Radiologic Drug Products

 

11:05     AAP Perspective                                                                                         John Ring, M.D.

                                                                                                                        University of Tennessee Health

Science Center

 

 

11:20     Cardiology Perspective                                                             Tal Geva, M.D.    

                                                                                                                        Boston Children’s Hospital                                                          

11:50     Q&A for Speakers

 

12:15     Lunch

 

1:15       Contrast Enhanced Cardiac Magnetic                                    Mark Fogel, M.D.

               Resonance Imaging                                                                     The Children's Hospital of

Philadelphia

 

1:45       Contrast Enhanced Cardiac                                                      Marilyn Siegel, M.D.

               Computed Tomography                                                              Washington University School of

Medicine

 

2:15       Contrast Enhanced Cardiac Ultrasound                                 Craig Sable, M.D.

                                                                                                                        University of Maryland School of

Medicine

 

2:45       Radiopharmaceuticals in Nuclear Cardiac Imaging           Vasken Dilsizian, M.D.

                                                                                                                        University of Maryland School of

Medicine

 

3:15       Q&A for speakers

 

3:45       Break

 

4:00       Open Public Hearing

 

5:00       Final Wrap-up and Adjourn

 

 

 

Pediatric Advisory Subcommittee of the Anti-Infective Drugs Advisory Committee

 

Food and Drug Administration

Center for Drug Evaluation and Research

ACS Conference Room, Room 1066, 5630 Fishers Lane, Rockville, MD

 

Draft Agenda for February 4, 2004

 

Use of Imaging Drugs  in Conjunction with

Cardiac Imaging Procedures in the Pediatric Population

 

8:00       Call to Order, Introductions:                                                   Joan P. Chesney, M.D., Chair

 

               Meeting Statement:                                                                     Thomas H. Perez, M.P.H.

Executive Secretary

 

8:15       Recap of Day 1                                                                             

 

8:30       Discussion of Questions to Committee

 

12:00     Adjourn