Suicidality Screening For All New Drugs Still On The Table After Draft Guidance
This article was originally published in The Pink Sheet Daily
FDA lists eight drug classes where it will recommend prospective assessment of suicidality risk, but it invites comments on broadening the criteria.
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Revised draft guidance retains eight categories of drugs to be evaluated for suicidal ideation and behavior in clinical trials, but says assessments could be conducted more broadly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.
Decisions on whether to add drugs or classes of drugs to a list FDA has published of investigational products that need suicidality assessments will be made at the division level, the agency says.