Data integrity holds: Another powerful FDA enforcement tool
FDA requested additional information about the antibiotic ceftobiprole, which is being jointly developed by J&J and Basilea Pharmaceutica AG
On March 19, 2008, The Wall Street Journal reported that: “The FDA made approval of ceftobiprole conditional on the inspection of study sites and review of clinical data received from the companies”
On Nov. 26, 2008, The Wall Street Journal further reported: “The FDA refused to approve the antibiotic, which treats MRSA and other serious infections, because of concerns about three sites involved in the study, a mix of U.S. and international locations ...”
FDA may be trying to avoid another Ketek
It seems clear that FDA is raising the bar on its expectations for
© 2009 Hogan & Hartson LLP. All rights reserved.