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,
Draft Agenda for
Meeting
Statement: Thomas
H. Perez, M.P.H.
Executive Secretary
Welcome: Office
of Pediatric
Therapeutics
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
Venlafaxine Hari Sachs, M.D.
Medical Officer
Division of Pediatric
Drug Development
11:45 Pediatric Update Dianne
Murphy, M.D.
Director, Office of Counter-terrorism and Pediatric Drug Development
Director,
Division of
Pediatric
Drug Development
Research
Involving Children The
Children’s Hospital of