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Some senior FDA staff are also predicting more aggressive enforcement

  • Deborah Autor, Director of CDER’s Office of Compliance, recently said that CDER enforcement actions will continue to rise in the foreseeable future

  • As an example, Autor reported that CDER’s Division of Scientific Investigations (DSI) has increasingly been issuing Warning Letters to clinical investigator and trial sponsors:

  • DSI issued 18 GCP Warning Letters in 2008, vs. none in 2004

  • Autor also said that CDER has started taking “swift aggressive

actions”

  • She warned that “If you are a company your head should be spinning”

  • At a recent FDA conference panel titled “FDA Enforcement: As It Was and Could Become” she gave the warning: “Be proactive.”

© 2009 Hogan & Hartson LLP. All rights reserved.

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