Ratzan, Judith M.D. – FDA Warning Letter, Sep 13, 2010

On February 16, 2011, the FDA issued a Warning Letter to Dr. Judith Ratzan following an inspection from July 19 to September 13, 2010, regarding her conduct of a clinical investigation (Protocol (b)(4)) of the investigational drug (b)(4). The inspection revealed significant violations of FDA regulations governing clinical investigations.

Key violations include: 1. **Failure to Personally Conduct or Supervise (21 CFR 312.60):** Dr. Ratzan failed to adequately supervise study staff, leading to multiple chemotherapy misadministrations for all three enrolled subjects, including administering an investigational drug after study closure. Her frequent absence from the clinical site was noted. 2. **Failure to Conduct Investigation According to Plan (21 CFR 312.60):** * **Chemotherapy Administration Deviations:** All three subjects experienced deviations in dose, infusion rate, or both. For Subject 2564977, (b)(4) was misdosed, and the investigational drug was administered for six cycles after the trial was clearly announced as closed. * **Missed Assessments:** Required assessments (e.g., UPC ratio, CEA test, history/physical) were not performed for all three subjects at various cycles and follow-up visits. * **Failure to Report Adverse Events:**