The objective of this guidance is to provide recommendations to industry for designing nonclinical late radiation toxicity studies to determine potential late radiation effects of therapeutic radiopharmaceutical agents. The purpose of conducting nonclinical late radiation toxicity studies is to help minimize the risk of late-occurring radiation toxicities in clinical trials of therapeutic radiopharmaceuticals. Because there are other guidances available for conventional nonclinical safety studies, this guidance focuses solely on late radiation safety concerns that are unique to therapeutic radiopharmaceuticals. These unique safety concerns result from the risk of irreversible late radiation toxicity when these agents deliver high doses of ionizing radiation to normal organs.
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.