Dr. Faranak Jamali is a senior medical officer/compliance reviewer in FDA’s Center for Drug Evaluation and Research (CDER), Office of Compliance (OC), Office of Scientific Investigations (OSI), Division of Enforcement and Post-marketing Safety (DEPS), Compliance Enforcement Branch (CEB). She has been with FDA for over 15 years of experience. In her current role, she is responsible for helping to ensure human subject safety and data integrity in clinical studies as part of FDA’s BIMO program. Previously, she has served FDA as a clinical reviewer in CDER’s Office of New Drugs (OND).
Her background education is in the field of anatomic and clinical pathology, and fellowships in hematopathology, transfusion medicine, and integrative medicine.
She has been one of the authors of a recently published FDA publications, “An FDA Analysis of Inspected Entities After Receiving Official Action Indicated Letters for Good Clinical Practice Violations,” in Therapeutic Innovation and Regulatory Science.