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Data integrity holds: Another powerful FDA enforcement tool

  • Ceftobiprole

    • 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

data integrity

© 2009 Hogan & Hartson LLP. All rights reserved.

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