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
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.”
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