Guidance for Industry on Nonclinical Evaluation of Late Radiation Toxicity of Therapeutic Radiopharmaceuticals; Availability

Streszczenie

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "Nonclinical Evaluation of Late Radiation Toxicity of Therapeutic Radiopharmaceuticals." The purpose of this guidance is to provide recommendations to industry 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. The purpose of such studies is to help minimize the risk of late-occurring irreversible radiation toxicities in clinical trials of therapeutic radiopharmaceuticals. This guidance finalizes the draft guidance of the same name issued in June 2005.