Guidance on Whether Radioactive Studies Require an Investigational New Drug (IND) Application
This post was written by Paul Sheives and Areta Kupchyk.
FDA has published a guidance document entitled “The Radioactive Drug Research Committee: Human Research Without an Investigational New Drug Application,” which provides information about the use of radioactive drugs for certain research purposes. FDA regulations allow for human research using a radioactive drug or biological product under a Radioactive Drug Research Committee approval only (i.e., without an IND) if it constitutes basic research and is not intended for immediate therapeutic, diagnostic, or similar purposes, or to determine the safety and effectiveness of the radioactive drug or biological product. The document describes what would constitute “basic research,” provides criteria for identifying such studies, and provides a frequently asked questions section on the topic.
