Federal Register Notice: FDA is making available a draft document entitled Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, dated April 2005. It provides sponsors of vaccine trials with recommendations on assessing the severity of clinical and laboratory abnormalities in healthy adult and adolescent volunteers enrolled in clinical trials. The guidance includes toxicity grading scale tables to use as a guideline for selecting the assessment criteria. To download this guidance, click here. To view this notice, click here.
