Sunandana Chandra, M.D. – FDA EIR, Oct 9, 2014

An FDA inspection of clinical investigator Jeffrey A. Sosman, M.D., in Nashville, TN, took place from August 22 to October 9, 2014. Conducted under the regulatory framework for Clinical Investigators and Sponsor Investigators (21 CFR 312.60), the inspection revealed significant and repeated violations of Good Clinical Practices (GCP) and Human Subject Protections (HSP). A Form FDA 483, Inspectional Observations, was issued. Main violations included the enrollment of subjects who did not meet eligibility criteria in both reviewed studies, failure to obtain proper informed consent, especially for continued treatment after disease progression, and delays in reporting serious adverse events (SAEs) and other adverse experiences to the study sponsors. Additionally, the inspection identified instances of prohibited concomitant therapies being administered, missed safety assessments, and failures to randomize subjects correctly. Inadequate and inaccurate case histories, including conflicting source documents, were also noted. Dr. Sosman was informed of his obligations to comply with regulations and the potential for enforcement actions, and he committed to providing a formal, written response to the findings.