FDA Rejects EPIX Appeal To Avoid New Trials

Law360, New York (August 28, 2006, 12:00 AM EDT) -- On Monday, the U.S. Food and Drug Administration denied an appeal from drug maker EPIX Pharmaceuticals Inc. to avoid a second round of trials for Vasovist, an injectible product already approved in Europe for use in magnetic resonance imaging (MRI).

The FDA’s Office of New Drugs suggested in a letter to EPIX that if the company decides to go forward with the additional clinical research, it should conduct two new clinical trials rather than rely on a blinded reread of previously submitted data.

EPIX, based in...
To view the full article, register now.