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Key Takeaways: GCP Enforcement

  • The agency is using more aggressive enforcement tools

  • (E.g. criminal prosecutions, data integrity holds on NDAs)

  • Despite regulations that permit companies to transfer regulatory

responsibilities to other parties, FDA still looks to sponsors as having ultimate responsibility for their products and studies

    • To the extent sponsors have delegated responsibilities, such as to CROs, they should review the memorialization of the delegation, and whether it is being implemented consistently

  • FDA GCP enforcement is branching out into new areas:

  • Safety reporting

  • Clinical investigator financial disclosure/ conflicts of interest

  • IRB oversight

© 2009 Hogan & Hartson LLP. All rights reserved.

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