2004N-0432 - Radioactive Drugs for Certain Research Uses; Public Meeting
FDA Comment Number : EC2
Submitter : Dr. Gregory Sorensen Date & Time: 12/15/2004 01:12:53
Organization : Massachusetts General Hospital / MIT
Health Professional
Category :
Issue Areas/Comments
GENERAL
GENERAL
The RDRC is a very valuable mechanism for clinical research. Please keep the RDRC system active and consider expanding the autonomy of the RDRC. In particular, the ability to understand disease by using tracer amounts of either novel or common medicinal compounds is a key facilitator of innovative research. A version of the RDRC that would allow trace amounts of a novel compound -- even one that had no IND -- to be administered by a qualified team of physicians, pharmacists, and/or radiobiologists would be a fantastic discovery and development tool that would greatly aid the battle to reduce morbidity and mortality.