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Ketek ushered in a new era of GCP enforcement

  • Ketek, approved in 2004, was later the subject of reports related to liver failure

  • FDA found that several Ketek clinical investigators had significant GCP violations and, in some cases, falsified data

  • One investigator is serving a four-year sentence after pleading guilty to

falsifying data

  • FDA issued a Warning Letter to Sanofi-Aventis on Oct. 23, 2007

    • In summary, our investigation found that Aventis did not adequately secure compliance of Dr. Kirkman Campbell. In addition, Aventis's method for securing compliance, (i.e., the generation of more than 125 memos to file for protocol and informed consent deviations noted at the site) was not adequate.

    • Although Aventis had contracted with PPD to conduct monitoring visits, Aventis conducted its own QA audits and conducted co-monitoring visits with PPD of Dr. Kirkman Campbell's site. As the sponsor of the NDA, Aventis retains responsibility for ensuring proper monitoring.

© 2009 Hogan & Hartson LLP. All rights reserved.

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