FDA Loss May Draw Drug-Device Makers To Policy Fight

Law360, New York (September 28, 2012, 7:39 PM EDT) -- A ruling that the U.S. Food and Drug Administration improperly classified a drug-and-device combination product as a drug — a more expensive designation that many sponsors try to avoid — may not change how the FDA designates combo products, experts say, but should encourage more unhappy sponsors to appeal.

A Washington, D.C., federal judge ruled Tuesday that the FDA had acted arbitrarily and capriciously when it designated a combination product made by the French company Prevor as primarily a drug, rather than a device. The product,...
To view the full article, register now.

Documents

Related

Sections

Case Information

Case Title

PREVOR v. UNITED STATES FOOD AND DRUG ADMINISTRATION


Case Number

1:11-cv-01187

Court

District Of Columbia

Nature of Suit

Other Statutory Actions

Judge

Rosemary M. Collyer

Date Filed

June 28, 2011

Law Firms

Government Agencies

UK Financial Services

UK Financial Services

Read Our Latest UK Financial Services Coverage

Financial Services Law360 UK provides breaking news and analysis on the financial sector. Coverage includes UK and European Union policy, enforcement, and litigation involving banks, asset management firms, and other financial services organizations.