Panels to Discuss Suicidality in Antidepressant Trials
10/31/2003
Federal Register Notice: FDA will hold a meeting of the Psychopharmacologic Drugs Advisory Committee and the Pediatric Subcommittee of the Anti-Infective Drugs Advisory Committee 2/2/04, from 8 a.m. to 5 p.m. at the Holiday Inn, Bethesda, MD. The committees will discuss reports of the occurrence of suicidality (both suicidal ideation and suicide attempts) in clinical trials for various antidepressant drugs in pediatric patients with major depressive disorder (MDD). The committee will consider optimal approaches to the analysis of data from these trials, and the results of analyses conducted to date, with regard to the question of what regulatory action may be needed pertinent to the clinical use of these products in pediatric patients. The committee will also consider further research needs to address questions on this topic. Contact Anuja Patel, (301) 827-7001. To view this notice, click here.
