Sofen, Howard – FDA EIR, Nov 15, 2016

An FDA inspection of Dr. Howard Sofen and Dermatology Research Associates, Inc., located in Los Angeles, CA, was conducted from November 7-15, 2016. The inspection, carried out under Compliance Program 7348.811 for Clinical Investigators, aimed to assess adherence to regulations governing clinical trials. The overall outcome of the inspection was positive, as no FDA Form 483, Inspectional Observation, was issued, indicating general compliance with regulatory requirements. However, one key discussion point arose during the close-out meeting. It was noted that a mild, non-study drug related adverse event (back pain for one subject) was documented in the subject's source documents but was not entered into the electronic Case Report Form (eCRF) and subsequently omitted from the data listings provided to the FDA. While the event was deemed unrelated to the study drug, complete reporting of all adverse events is a regulatory expectation. The inspection also noted a previous VAI classification in April 2008 for protocol adherence deficiencies, including incorrect study article dispensing. During the current inspection, a similar issue of an incorrect study kit being dispensed was identified but confirmed to have been adequately reported to both the Sponsor and the Institutional Review Board (IRB). Management at Dr. Sofen's site acknowledged the oversight regarding the unreported adverse event and committed to making the necessary corrections to ensure comprehensive reporting in the future. No further formal regulatory actions were mandated by the FDA as a result of this inspection.