The Radioactive Drug Research Committee (RDRC) operates under the purview of the Food and Drug Administration
in accordance with
FDA regulation 21 CFR 361.1
. The Committee reviews, approves, and provides ongoing oversight of research studies involving radioactive drugs in humans that fall under the RDRC's purview, as defined in FDA regulation 21 CFR 361.1.
The Committee meets quarterly and is made up of at least five individuals as follows:
- A physician recognized as a specialist in nuclear medicine [§ 361.1(c)(1)].
- A person qualified by training and experience to formulate radioactive drugs [§ 361.1(c)(1)].
- A person with special competence in radiation safety and radiation dosimetry [§ 361.1(c)(1)].
- Individuals qualified in various disciplines pertinent to the field of nuclear medicine (e.g., radiology, internal medicine, clinical pathology, hematology, endocrinology, radiation therapy, radiation physics, radiation biophysics, and radiopharmacy) [§ 361.1(c)(1)].
Approved qualified investigators require both RDRC approval and the approval of the IRB before the study may begin.
If you have any questions please contact Committee Coordinator at 303-724-4743 or send an
email to firstname.lastname@example.org