FDA Restricts Clinical Trial Review Board Over Safety

Law360, New York (August 27, 2009, 1:57 PM EDT) -- Institutional review board Coast IRB LLC agreed Tuesday to stop reviewing new research studies regulated by the U.S Food and Drug Administration, after the agency expressed serious concerns over whether the company could protect human subjects participating in the clinical trials it oversees.

After receiving a warning letter from the FDA, Coast voluntarily stopped taking new studies and halted the enrollment of new subjects in the studies it currently reviews.

The FDA's actions follow on the heels of a recent undercover operation conducted by the U.S....
To view the full article, register now.

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.