MEDICAL IMAGING AGENT NDAs SHOULD INCLUDE QUANTITATIVE IMAGE QUALITY DATA, FDA SAYS; VALUE OF QUALITATIVE EVALUATIONS EMPHASIZED BY PANEL MEMBERS
This article was originally published in The Gray Sheet
Executive Summary
Medical imaging agent studies should include quantitative data as well as qualitative endpoints, Eric Jones, group leader in FDA's Division of Medical Imaging Drugs, said Oct. 27 at a meeting of the agency's Medical Imaging Drugs Advisory Committee in Silver Spring, Maryland.