Changes in the approval process for contrast media

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 The draft guidance also disregard ed that indications for imaging agents are often general and not disease sp ecific.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.