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 June 9, 2004

 

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

 

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

Executive Secretary

 

               Welcome:                                                                                      Office of  Pediatric Therapeutics

                                                                                                                       

8:20       Adverse Event Reports per Section 17 of BPCA                   Solomon Iyasu, M.D.

                                                                                                                        Lead Medical Officer

                                                                                                                        Division of Pediatric

Drug Development

 

                              Fexofenodine                                                                 Jane Filie, M.D.

                                                                                                                        Medical Officer

                                                                                                                        Division of Pediatric

                                                                                                                        Drug Development

 

                              Topotecan                                                                       Susan McCune, M.D.

                              Temozolomide                                                               Medical Officer

                                                                                                                        Division of Pediatric

                                                                                                                        Drug Development

 

                              Moxifloxacin                                                                  Harry Gunkel, M.D.

                              Ciprofloxacin                                                                Medical Officer

                                                                                                                        Division of Pediatric

                                                                                                                        Drug Development

 

                              Fosinopril                                                                      Larry Grylack, M.D.

                                                                                                                        Medical Officer

                                                                                                                        Division of Pediatric

                                                                                                                        Drug Development

 

                              Fentanyl                                                                          ShaAvhree Buckman, M.D.

                                                                                                                        Medical Officer

                                                                                                                        Division of Pediatric

                                                                                                                        Drug Development

 

           

10:00     Break

 

10:15     Adverse Event Reports per Section 17 of BPCA (cont.)

 

                              Venlafaxine                                                                     Hari Sachs, M.D.

                                                                                                                        Medical Officer

                                                                                                                        Division of Pediatric

                                                                                                                        Drug Development

 

 

 

11:15     Open Public Hearing

 

11:45     Pediatric Update                                                                          Dianne Murphy, M.D.

Director, Office of Counter-terrorism and Pediatric Drug Development

Noon      Lunch

 

1:00       Update on Neonatal Withdrawal Syndrome

 

2:45       Update on Congenital Eye Malformations in Infants

 

3:00       Break

 

3:15       Open Public Hearing

 

3:45       Pediatric Research Equity Act (PREA) Update                    Shirley Murphy, M.D.

                                                                                                                        Director, Division of

                                                                                                                        Pediatric Drug Development

 

4:00       Overview of IOM Report, Ethical Conduct of Clinical        Robert Nelson, M.D., Ph.D.

Research Involving Children                                                      The Children’s Hospital of

                                                                                                         Philadelphia

 

 

4:45       Final Comments and Adjourn