DRAFT Agenda

Pediatric Advisory Committee Meeting

April 11, 2007

Advisory Committee Conference Room, Room 1066

5630 Fishers Lane, Rockville, Maryland

 

4:00     Welcome and                                                 Marsha Rappley, MD, Chair

Introductory Remarks                                  Dean, College of Human

Medicine

                                                                                    Michigan State University

 

                                                                                    Carlos Peña, PhD, MS

Executive Secretary,

Office of Science and Health        Coordination

FDA, OC

 

4:10     Meeting Overview                                         Dianne Murphy, MD

Director,

Office of Pediatric Therapeutics

FDA, OC

4:15     Open Public Hearing

 

            Adverse Event Reporting as per Section 17 BPCA

Fluvastatin (Lescol®)                                     Amy Taylor, MD, MHS, FAAP

                                                                                    Medical Officer,

                                                                                    Pediatric and Maternal Health Staff

                                                                        CDER

 

Octreotide (Sandostatin®)                             Amy Taylor, MD, MHS, FAAP

Discussion and Q&As

           

            Updates to the Committee

 

            Orlistat (Xenical®)                                         Hari Sachs, MD, FAAP

                                                                                    Medical Officer,

                                                                                    Pediatric and Maternal Health Staff

                                                                                    CDER

 

            Oxybutynin (Ditropan®)                                Andrew D. Mosholder, MD, MPH

                                                                                    Division of Drug Risk Evaluation

                                                                                    CDER

Discussion and Q&As

 

6:00     Adjourn