FDA Draft Guidance on Occurrence of Suicidality in Clinical Trials
This post was written by Paul Sheives.
FDA has issued a draft guidance entitled “Suicidality: Prospective Assessment of Occurrence in Clinical Trials,” which is intended to help sponsors to prospectively assess the occurrence of treatment-emergent suicidality in clinical trials of drug and biological products. In the draft guidance, FDA recommends the use of a particular suicidality assessment instrument to proactively query patients about the occurrence of suicidal thinking and behavior, as opposed to relying on patient-initiated reports. FDA is accepting written comments on the draft guidance.
