FDA To Crack Down On Drug-Coated Stents: Report

Law360, New York (December 17, 2007, 12:00 AM EST) -- The U.S. Food and Drug Administration is reportedly planning to turn a more critical eye toward drug-coated stents in the next few weeks by bolstering its testing requirements in response to safety concerns over the devices.

The regulatory agency will soon publish a draft of new guidelines for the stents, the FDA’s device chief, Daniel Schultz, told The Wall Street Journal on Thursday.

The new standards will likely discuss the numbers of patients on whom new drug-eluting stents must be tested, and for how long, both...
To view the full article, register now.