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FDA’s oversight of safety reporting will intensify

  • Consistent with FDAAA’s emphasis on safety, FDA appears to

be placing greater scrutiny on adverse event reporting

  • In its March 25, 2008, Warning Letter to GSK, FDA wrote:

    • Our inspection revealed that your firm failed to report data relating to clinical experience, along with other data and information, for Avandia …. In particular, the inspection found that your firm failed to report multiple postmarketing studies involving Avandia in mandatory Periodic and/or NDA Annual Reports.

    • [Your 483] response is inadequate because it does not explain how your firm will ensure that it has submitted to FDA all mandatory postmarketing reporting information concerning its approved drug products. FDA's inspection revealed that your firm lacked appropriate knowledge of the studies associated with Avandia, resulting in the reporting deficiencies noted. Absent a clear explanation of the extent and cause of these deficiencies and an adequate plan to correct them, we are concerned that similar deficiencies in the postmarket reporting for your firm's other FDA-approved drugs may exist.

© 2009 Hogan & Hartson LLP. All rights reserved.

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