Draft Guidance for Industry on Nonclinical Evaluation of Late Radiation Toxicity of Therapeutic Radiopharmaceuticals; Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Nonclinical Evaluation of Late Radiation Toxicity of Therapeutic Radiopharmaceuticals." The purpose of this draft guidance is to provide recommendations to industry for designing nonclinical toxicity studies to determine potential late radiation toxicities (radiation- induced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. The purpose of such studies is to help minimize the risk of late- occurring irreversible radiation toxicities in clinical studies of therapeutic radiopharmaceuticals.