•June, 2003: Regulatory responses to paroxetine signal by MHRA (UK) and FDA
•July, 2003: FDA request to sponsors of 8 other antidepressant products for pediatric suicidality summary data (modeled after GSK approach)
•Aug, 2003:
Re-evaluation of suicidality data from 8 pediatric supplements
•Aug, 2003:
Wyeth labeling change and Dear Health
Care Professional letter for Effexor, and regulatory responses (MHRA)
•Sept, 2003: FDA internal
regulatory briefing
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