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Key Takeaways: General Considerations

  • FDA is ramping up its enforcement with new staff and increased budget

  • The new administration and FDA leadership are likely to be more

enforcement-oriented

  • Congressional action will force FDA to be more active

  • FDA is now leveraging its resources (for example, collaborating with

foreign countries and U.S. DOJ) and using stronger tactics

  • FDA expects companies to aggressively correct any quality and compliance issues as soon as they are discovered

  • FDA is looking behind contractual and corporate arrangements more frequently

  • In certain cases, FDA may ask to see internal GMP/GCP audit reports

© 2009 Hogan & Hartson LLP. All rights reserved.

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