FDA Drops “Suicidality” Term, Urges Broader Risk Assessment During Development
Revised draft guidance retains eight categories of drugs to be evaluated for suicidal ideation and behavior in clinical trials, but says assessments could be conducted more broadly and “encourages” sponsors to discuss the possibility with the review division.
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FDA lists eight drug classes where it will recommend prospective assessment of suicidality risk, but it invites comments on broadening the criteria.
One suicide and 48 suicidal ideation cases reported following treatment with Acomplia between June 2006 and May 9.
Industry also seems supportive of the idea, while Pew touts the power of the power of track-and-trace as a deterrent.