The NIH Radioactive Drug Research Committee (RDRC) functions as a subcommittee of the Radiation Safety Committee and is mandated by the Food and Drug Administration (FDA) Regulations 21 CFR Part 361.1, “Radioactive Drugs for Certain Research Uses”, to review and approve the use of radioactive drugs for research purposes in humans for which an approved NDA (New Drug Application) or an approved INDA (Investigational New Drug Application) does not exist.

The RDRC Application for Human Subject Research Using Research Radioactive Drug must be submitted with your 88-23(a) application. More information on submitting a Clinical Protocol application can be found in the Clinical Protocol Information section.

Duties of the Committee | List of RDRC members