FDA Posts Draft Guidance to Assist Sponsors in Assessing Suicidal Ideation and Behavior in Clinical Trials

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Company News Release

The FDA issued this Revised Draft Guidance titled "Guidance for Industry Suicidal Ideation and Behavior: Prospective Assessment of Occurrence in Clinical Trial" for the purpose of comment, and the purpose of the Guidance as stated by the FDA is "to assist sponsors in prospectively assessing the occurrence of treatment-emergent suicidal ideation and behavior in clinical trials of drug and biological products." Click the link to get to the PDF.