Draft Guidance for Industry and Researchers on the Radioactive Drug Research Committee: Human Research Without an Investigational New Drug Application; Availability

Streszczenie

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry and researchers entitled "The Radioactive Drug Research Committee: Human Research Without an Investigational New Drug Application." This draft guidance provides information to those using radioactive drugs for certain research purposes to help determine whether research studies may be conducted under an FDA-approved radioactive drug research committee, or whether research studies must be conducted under an investigational new drug application (IND). It also offers answers to frequently asked questions on conducting research with radioactive drugs, and provides information on the membership, functions, and reporting requirements of a radioactive drug research committee approved by FDA.