The University of Virginia's Radioactive Drug Research Committee (RDRC) is a standing committee and is responsible for reviewing and approving all radioactive drug research projects which fall under the U.S. Food and Drug Administration (FDA) regulations as specified in 21 Code of Federal Regulations Part 361.1. Research projects which meet the criteria for review as outlined in the regulations must be submitted to and approved by the RDRC prior to initiation of the study. Institutional Review Board approval is also required before initiation of the study. The RDRC operates in accordance with 21 CFR Part 361.
RDRC approval is required for radioactive drugs and agents that are not approved by the FDA or are not being used under an FDA approved IND (Investigational New Drug application).
The RDRC program permits basic research regarding metabolism, physiology, pathophysiology, or biochemistry - it is not intended for therapeutic or diagnostic purposes or determination of safety and effectiveness.
Committee members are appointed by the University of Virginia's Vice President for Research and approved by the FDA.
Researchers can submit a study proposal for the RDRC to review by using the RDRC's online application (log-in).
|Date of RDRC Meeting
Stuart S. Berr, PhD
Physician Recognized as a Specialist in Nuclear Medicine
Prem Batchala, MD
Person Qualified by Training and Experience to Formulate Radioactive Drugs
Shivashankar Khanapur, PhD
Persons with Special Competence in Radiation Safety and Radiation Dosimetry
Andrew Polemi, PhD
Nick J Dorrell, CHP, RRPT
Other Voting Members
Kelly Hochstetler, PhD