BioCentury
ARTICLE | Regulation

Judge keeps the lid on

June 23, 1997 7:00 AM UTC

WASHINGTON - U.S. District Court Judge Paul Friedman last week rejected a motion filed by Sonus Pharmaceuticals Inc. (SNUS, Bothell, Wash.) to allow FDA to schedule an advisory panel meeting for the company's EchoGen contrast agent. Friedman's action continues the current freeze on all regulatory activity related to several fluorocarbon gas bubble-based ultrasound contrast products.

Under FDA rules, the agency is supposed to reply to the first of several citizens petitions filed by ultrasound imaging companies opposed to the FDA's review of Molecular Biosystem Inc.'s FS069 as a device (see BioCentury April 28). ...