FDA: Guidance for Industry. Suicidality: Prospective Assessment of Occurrence in Clinical Trials

The purpose of this guidance is to assist sponsors in prospectively assessing the occurrence of treatment-emergent suicidality in clinical trials of drug and biological products.2 Specifically, this guidance addresses the Food and Drug Administration’s (FDA’s) current thinking regarding the importance of suicidality assessment in psychiatric and nonpsychiatric drug trials and the general principles for how best to accomplish this assessment during drug development.