This paper discusses, from an academic perspective, the changes proposed by
the Food and Drug Administration (FDA) regarding the approval process for
contrast media, The proposed changes are extensive, covering indications, s
afety and efficacy assessments, and image acquisition and handling, The dra
ft guidance unfortunately grouped together therapeutics and diagnostics. In
dications were divided into the following categories: a) structure delineat
ion, b) functional physiological, or biochemical assessment, c) disease or
pathology detection/assessment, and d) diagnostic or therapeutic patient ma
nagement. Such a division would greatly complicate the approval process, re
quiring multiple trials to gain approval. The draft guidance also disregard
ed that indications for imaging agents are often general and not disease sp
ecific. As issued, it implied that separate trials would be required for ea
ch clinical setting where lesions might be important. As the standard of tr
uth, blinded reads with no clinical information were proposed as the primar
y endpoint, This ignores how diagnostic exams we interpreted and the value
of medical history. (C) 1999 Wiley-Liss, Inc.