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Guidance on Vaccine Trial Toxicity Scale

09/27/2007

Federal Register Notice: FDA is making available a document entitled Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials. The document 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, including toxicity grading scale tables to use as a guideline for selecting the assessment criteria. This guidance finalizes a 4/05 draft guidance of the same title. To download this guidance, click here. To view this notice, click here.

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