FDA Requests Adult Antidepressant Suicidality Data
This article was originally published in The Pink Sheet Daily
Executive Summary
The agency's review of adult suicidality data will take at least a year to complete, FDA says in a Public Health Advisory. Manufacturers of antidepressants are being asked to review all placebo-controlled trials in adult patients using methodology similar to that used to analyze suicidality in pediatric trials.
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