Radioactive Drug Research Committee (RDRC)

Description

The RDRC evaluates and approves or disapproves of applications involving investigational or non-routine clinical uses of radioactive drugs without New Drug Applications (NDA) filed with the FDA or without Investigational New Drug (IND) numbers issued by the FDA. The RDRC reports directly to the United States Federal Drug Agency (FDA) and must ensure compliance with 21 CFR 361.1.

ERICA Online

ERICA is the data management system used by the University of Utah's Institutional Review Board (IRB) and its ancillary committees for human use study reviews. If you have more questions regarding ERICA or IRB, please visit the IRB Website.

References

University of Utah RPR 48-2: Radioactive Drug Research Committee

Radioactive Drug Research Committee (RDRC) and Human Use Subcommittee of the Radiation Safety Committee (HUS-RSC)

Code of Federal Regulations: Title 21, Chapter I, Subchapter D, Part 361, Section 361.1: Radioactive Drugs for Certain Research Uses

Reporting Structure

Current Roster


Chair
Shane Lloyd, MD
Required Members
Physician(s) recognized as specialist(s) in nuclear medicine	Nikolas Damme, MD
	Satoshi Minoshima, MD
Person(s) qualified by training and experience to formulate radioactive drugs	Jeff Krysten, MS, RPh, BCNP
	Isaiah Springer, Pharm.D., RPh
Person(s) with special competence in radiation safety and radiation dosimetry	Jeffrey T. Yap, Ph.D.
	Peter Jenkins, Ph.D., CHP
Other Voting Members
	Shane Lloyd, MD
	Scott C. Miller, Ph.D.
	David Moody, Ph.D.
	Vikren Sarkar, Ph.D., DABR
	Megan Mills, MD
	Eugene Kim, MD
Non-Voting Members
	Frederick A. Monette, MS, CHP