Does FDA approve RDRCs?
Yes. An RDRC must obtain and maintain approval by the Food and Drug Administration, as outlined in 21 CFR 361.1(c). RDRCs must register with the Division of Medical Imaging and Radiopharmaceutical Drug Products, (HFD-160), Center for Drug Evaluation and Research, FDA, 5600 Fishers Lane, Rockville, Maryland 20857. The FDA contact for compliance issues is the Human Subject Protection Team (HFD-343), CDER, FDA, 7520 Standish Place, Rockville, MD 20855.
