Guidance on Therapeutic Radiopharmaceuticals Toxicity
06/20/2005
Federal Register Notice: FDA is making available a draft guidance for industry entitled Nonclinical Evaluation of Late Radiation Toxicity of Therapeutic Radiopharmaceuticals. The guidance is intended to provide recommendations to industry for designing nonclinical toxicity studies to determine potential late radiation toxicities (radiation-induced injuries occurring after a latency period of several months to years) of therapeutic radiopharmaceuticals administered systemically. These studies are conducted to help minimize the risk of late-occurring irreversible radiation toxicities. To download this guidance, click here. To view this notice, click here.
