The purpose of this guidance is to assist sponsors in prospectively assessing the occurrence of treatment-emergent suicidal ideation and behavior in clinical trials of drug and biological products.2 The focus of this guidance is on clinical trials conducted under investigational new drug applications, or trials that are intended for submission in a new drug application or a biologics license application. Specifically, this guidance addresses the Food and Drug Administration’s (FDA’s) current thinking regarding the importance of assessment of suicidal ideation and behavior in psychiatric and nonpsychiatric drug trials falling under the authority of the FDA, and the general principles for how best to accomplish this assessment during drug development. This guidance is not intended to give advice on how best to screen patients for entry into clinical trials, even though instruments used for assessing patients during the conduct of trials can also be used for screening patients. Making decisions about which patients to enter into a particular trial is a separate matter that is determined largely by the questions that the trial is intended to address.
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.