2004N-0432 - Radioactive Drugs for Certain Research Uses; Public Meeting
FDA Comment Number : EC1
Submitter : Dr. Bradley Christian Date & Time: 12/15/2004 01:12:46
Organization : Kettering Medical Center
Category :
Issue Areas/Comments
Re: RDRC Membership Issue #1

I do not feel the RDRC would benefit by requiring the membership of a pharmacologist or toxicologist. Given that radiotracer doses, by definition, do not cause a clinically detectable effect, the expertise of such an individual would be useless. From a logistical standpoint, pharmocologists and toxicologists are typically not active in the development of radiopharmaceuticals. As a result, most academic research centers do not have access to such individuals and the prospect of finding a willing pharmacologist / toxicologist with experience in radiotracer development is unlikely.

A better option would be to set a lower injected mass limit, as discussed at the public forum.