Federal Register Notice: FDA is making available a guidance, Nonclinical Evaluation of Late Radiation Toxicity of Therapeutic Radiopharmaceuticals. It aims to provide recommendations for designing nonclinical toxicity studies to determine potential late radiation effects (radiation-induced injuries occurring after a latency period of several months to years) of therapeutic radiopharmaceuticals administered systemically. This guidance finalizes a 6/2005 draft guidance. To download this guidance, click here. To view this notice, click here.