Diagnostic Study Results Misrepresented by Website

Bracco Diagnostics made false and unsubstantiated claims about its diagnostic agent Isovue and omitted or minimized risks on a website that based the claims on a clinical study, an FDA untitled letter says. The Division of Drug Marketing, Advertising and Communications cited the company for several pages of the website that falsely indicated that the IMPACT study was a prospective trial comparing the primary endpoint of incidence of contrast-induced nephropathy between Isovue (iopamidol) and GE Healthcare’s Visipaque (iodixanol), which are used in cardiovascular imaging. The web pages have since been taken down, the company said.
Clinical Trials Advisor