Pediatric Advisory Committee June 29, 2005 Dianne Murphy, MD Director, Office of Pediatric Therapeutics OC, FDA. OVERVIEW OF FDA’S PEDIATRIC ADVISORY COMMITTEE ACTIVITIES. Review of Pediatric Expert Panel Activities: An Evolving Process.
June 29, 2005
Dianne Murphy, MD
Director, Office of Pediatric Therapeutics
OC, FDAOVERVIEW OF FDA’S PEDIATRIC ADVISORY COMMITTEE ACTIVITIES
Use of Imaging Drugs in conjunction with cardiac imaging procedures in the pediatric population
Suicidality in clinical trials for anti-depressant drugs in pediatric patients: the issues and the approach.
Tracking Cancer Risk among Children with Atopic Dermatitis who are treated with Topical Calcineurin Inhibitors
Discussion of approach to improving BPCA safety reporting to the pediatric advisory committee
Potential cancer risk in children from use of topical calcineurin inhibitors
Losartan1-Year Post-ExclusivityReporting of Adverse EventsJune & October, 2003; February 2004
Fentanyl1-Year Post-ExclusivityReporting of Adverse EventsJune 2004
Glyburide/metformin1-Year Post-Exclusivity ReportingSeptember 2004 and February 2005
Detrol and Detrol LA –Tolterodine tartrate
Arava – Leflunomide
Concerta – OROS Methylphenidate1-Year Post-ExclusivityReporting of Adverse EventsJune 2005
Pediatric Advisory Panels for either Ethical or Scientific Discussions: 19
Pediatric Advisory Panels to review adverse events for Exclusivity: 7
Products Reviewed for Adverse Events under BPCA mandate : 42
New safety information identified for almost a dozen products used to treat children. Examples are: antidepressants, pain patches, products for treatment of asthma
ODS Adverse Event and Use Reviews
Exclusivity Studies ( Medical and Pharmacology Reviews)
Pediatric Division Slides
Job very well done!
But there is much more to come.
Upcoming Issues: Obesity and therapeutic interventions
More Ethical issues involving Trial Design