Food and Drug Administration

Psychopharmacologic Drugs Advisory Committee


Pediatric Subcommittee of the

Anti-Infective Drugs Advisory Committee

February 2, 2004


Overview of Pediatric Drug Development, Dr. Dianne Murphy, MD, FDA (HTM) (PPT)

Pediatric Depression and It's Treatment, Dr. Cynthia Pfeffer, MD, Cornell Universigy (HTM) (PPT)

Suicide and Related Problems in Adolescence, David Shaffer, Columbia University (HTM) (PPT)

Drug Utilization for Selected Antidepressants Among Children & Adolescents in the U.S., Dr. Gianna Rigoni, PharmD, MS, FDA (HTM) (PPT)

One Year Post Exclusivity Adverse Event Review as Mandated by the Best Pharmaceuticals for Children Act, Dr. Solomon Iyasu, MD, MPH, FDA and Dr. Hari Sachs, MD, FAAP, FDA (HTM) (PPT)

Office of Drug Safety Data Resources for the Study of Suicidal Events Associated With Pediatric Use of Antidepressants, Dr. Andrew Mosholder, MD, MPH, FDA (HTM) (PPT)

Brief Regulatory History of Antidepressants and Suicidality and Update on Current Plans for Analysis of Pediatric Suicidality Data From Controlled Trials, Dr. Thomas Laughren, MD, FDA (HTM) (PPT)

Suicidality Classification Project, Dr. Kelly Posner, PhD and Dr. Maria Oquendo, MD (HTM) (PPT)

Plans for Analysis of Patient Level Data for Pediatric Studies, Dr. Tarek Hammand, MD, PhD, MSc, MS, FDA (HTM) (PPT)

Questions - 1st Half (HTM) (PPT)

Questions - 2nd Half (HTM) (PPT)

Open Publich Hearing

Speakers List (HTM) (PPT)

Power to Harm - SSRI-Induced Suicide, Sara Bostock (HTM) (PPT)

Presentation by Steve Cole Regarding His Father Milton Cole (HTM) (PPT)

SSRIs, Efficacy, Safety & Children: Ethical and Scientific Concerns, Dr. Julie Zito, PhD, University of MD (HTM) (PPT)