Zdrowie i gospodarka · 15/02/2005

Draft Guidance for Industry on Internal Radioactive Contamination-Development of Decorporation Agents; Availability

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Internal Radioactive Contamination--Development of Decorporation Agents." This draft 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 medical products not previously marketed or new indications for previously marketed products. Specifically, this draft guidance addresses chemistry, manufacturing and controls (CMC) information; animal efficacy, safety pharmacology, and toxicology studies; clinical pharmacology,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.