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.

RDRC Meeting Schedule

Date of RDRC Meeting Location Time
TBA TBA TBA

RDRC Members

Stuart S. Berr, PhD
Chair

Lale Kostakoglu, MD
Physician Recognized as a Specialist in Nuclear Medicine

Luke Lancaster, MD
Physician Recognized as a Specialist in Nuclear Medicine

Darci Sidwell, RPh, PharmD
Person Qualified by Training and Experience to Formulate Radioactive Drugs

Kiel Neumann, PhD, Director Radiochem Lab
Person Qualified by Training and Experience to Formulate Radioactive Drugs

Allen R. Goode, MS, DABR
Person with Special Competence in Radiation Safety and Radiation Dosimetry

Nick J Dorrell, CHP, RRPT
Person with Special Competence in Radiation Safety and Radiation Dosimetry

Mike Welling, UVA Radiation Safety Officer
Person with Special Competence in Radiation Safety and Radiation Dosimetry

David Hudson, Senior Associate Vice President for Research
Voting Member

Technical Contact

Vaughn C. Kowahl, Chief Technology Officer / IT-Director - Office of the Vice President for Research

 
 
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