Food and Drug Administration

Pspychopharmacologic Drugs Advisory Committee

and the

Pediatric Advisory Committee

September 13, 2004


Occurrence of Suicidality in Clinical Trials for Antidepressant Drugs in Pediatric Patients, Dr. Dianne Murphy, MD, FDA (HTM) (PPT)

Regulatory Background on Antidepressants and Suicidality in Pediatric Patients, Dr. Thomas Laughren, MD, FDA (HTM) (PPT)

Recent Observational Studies of Antidepressants (ADs) and Suicidal Behavior, Dr. Diane Wysowski, PhD, FDA (HTM) (PPT)

Treatment for Adolescents With Depression Study - Stage 1ITT Outcomes, Dr. John March, MD, MPH, FDA (HTM) (PPT)

Characteristics of Pediatric Antidepressant Trials, Dr. Gregory Dubitsky, MD, FDA (HTM) (PPT)

Suicidality Classification Project, Dr. Kelly Posner, PhD, et. al.(HTM) (PPT)

Audit of the Columbia Suicidality Classification Project, Dr. Solomon Iysu, MD, MPH, FDA (HTM) (PPT)

Results of the Analysis of Suicidality in Pediatric Trials of Newer Antidepressants, Dr. Tarek Hammad, MD, PhD, MSc, MS, FDA (HTM) (PPT)

Comparison Between Original ODS and Current DNDP Analyses of Pediatric Suicidality Data Sets, Dr. Andrew Mosholder, MD, MPH, FDA (HTM) (PPT)

Citalopram and Escitalopram Pediatric Safety Data, Dr. Jeffrey Jonas, MD, Forest Research Institute (HTM) (PPT)

Sertraline Use in Pediatric Population: A Risk Benefit Discussion, Dr. Steven Romano, MD, Pfizer Pharmaceuticals (HTM) (PPT)

Wyeth Pharmaceuticals Presentation, Dr. Joseph Camardo, MD (HTM) (PPT)

Event-Based Outcomes (HTM) (PPT)

Open Public Hearing

Open Public Hearing Speakers (HTM) (PPT)

Statement by Andrew Chmilewsky (HTM) (PPT)

Statement by Depression and Bipolar Support Alliance (HTM) (PPT)

Statement by Sara Bostock (HTM) (PPT)

Statement by Kim Witczak (HTM) (PPT)

Statement by Dr. David Risinger, MD (HTM) (PPT)

A Clinical Perspective on Safety and Efficacy of SSRIs in Depressed Children and Adolescents, Dr. J. Mann, MD, American Foundatio for Suicide Prevention (HTM) (PPT)