Federal Register Notice: FDA is making available a guidance for industry entitled Internal Radioactive Contamination — Development of Decorporation Agents. This document provides guidance to industry on the development of decorporation agents for treating internal radioactive contamination when evidence is needed to demonstrate the effectiveness of the agents, but human efficacy studies are unethical or infeasible. The animal efficacy rule may be invoked to approve new decorporation agents not previously marketed or new indications for previously marketed drug products. The guidance addresses chemistry, manufacturing, and controls information; animal efficacy, safety pharmacology, and toxicology studies; clinical pharmacology, biopharmaceutics, and human safety studies; and postapproval commitments. To download this guidance, click here. To view this notice, click here.