FDA WARNING_LETTER - Michelson, Joseph B., M.D. - August 24, 2010

An FDA inspection conducted between July 26 and August 24, 2010, by Thomas R. Beilke, reviewed the conduct of a clinical investigation (Protocol (b)(4)) performed by Joseph B. Michelson, M.D., who became the clinical investigator on March 2, 2009. The inspection, part of the Bioresearch Monitoring Program, concluded that Dr. Michelson did not adhere to applicable statutory requirements and FDA regulations governing clinical investigations. The primary violation identified was the failure to ensure the investigation was conducted according to the investigational plan, as required by 21 CFR 312.60. Specific deficiencies included enrolling subjects with off-center optical coherence tomography (OCT) scans, which potentially made ineligible subjects appear eligible, and failing to administer the specified (b)(4) treatment to six of 18 enrolled eyes as required by the protocol. The FDA noted that keeping these subjects in the study compromised data integrity. Dr. Michelson is required to notify the FDA in writing within fifteen working days of receipt of the letter, detailing actions taken to prevent similar violations. Failure to adequately address these violations may result in further regulatory action.