FDA’nın yeni taslak kılavuzu klinik çalışmalara katılan hastalarda intihar düşüncesi ve davranışına yönelik…(İng)
New FDA Draft Guidance: Guidance for Industry Suicidal Ideation & Behavior: Prospective Assessment of Occurrence in Clinical Trial
As per the FDA Draft Guidance: “The purpose of this guidance is to assist sponsors in prospectively assessing the occurrence of treatment-emergent suicidal ideation and behavior in clinical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. 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.”