•Sept-Oct, 2003: Responses to FDA’s 7-22-03 requests for summary data for other antidepressants
•Oct, 2003:
Updated FDA Public Health Advisory and Talk Paper
•Oct, 2003:
FDA request to sponsors of all 9 antidepressant
products for patient level pediatric study data sets
•Oct, 2003:
Decision to seek outside review and reclassification
of clinical events
•Nov-Dec, 2003: Second request for identification of events of potential interest with regard to
suicidality
•Dec, 2003:
Most recent action by MHRA regarding antidepressant
use in pediatric MDD