E-mails Question FDA Review Process For Ketek

Law360, New York (July 19, 2006, 12:00 AM EDT) -- Several recently uncovered e-mails have exposed concern by Food and Drug Administration officials that the agency’s approval of a bronchitis treatment marketed by Sanofi-Aventis was a potentially lethal mistake.

An FDA official, David Graham, sent an e-mail last month questioning the approval of the drug, sold under the name Ketek, and claiming that the review process was fraught with error and oversight, the New York Times reported.

“It's as if every principle governing the review and approval of new drugs was abandoned or suspended where telithromycin...
To view the full article, register now.

Law360 UK

UK Financial Services

Read Our Latest UK Legal News & Analysis

Financial Services Law360 UK and Insurance Law360 UK provide breaking news and in-depth analysis on U.K. and European Union regulation, enforcement, legislation, and litigation involving banks, investment firms, insurers, and more.