Department of Health and Human Services March 2, 2006 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Internal Radioactive ContaminationDevelopment of Decorporation Agents.'' This document provides guidance to industry on the development of decorporation agents for the treatment of internal radioactive contamination when evidence is needed to demonstrate the effectiveness of the agents, but human efficacy studies are unethical or infeasible. In such instances, the animal efficacy rule may be invoked to approve new decorporation agents not previously marketed or new indications for previously marketed drug products. Specifically, this guidance addresses chemistry, manufacturing, and controls (CMC) information; animal efficacy, safety pharmacology, and toxicology studies; clinical pharmacology, biopharmaceutics, and human safety studies; and postapproval commitments.