FDA WARNING_LETTER - Nassim, Omid M.D. - December 05, 2012

The FDA issued a Warning Letter to Omid Nassim, M.D., of Alia Clinical Research, Inc., following an inspection conducted between October 12 and December 5, 2012. The inspection reviewed clinical investigations of the investigational drug BI 10773 (empagliflozin) for Boehringer Ingelheim Pharmaceuticals (Protocols 1245.23 and 1245.25). The FDA concluded that Dr. Nassim did not adhere to applicable statutory requirements and FDA regulations governing clinical investigations. Two main violations were identified: 1) Failure to ensure the investigation was conducted according to the investigational plan (21 CFR 312.60), specifically enrolling five subjects into Protocol 1245.25 who did not meet the high cardiovascular risk inclusion criteria, which jeopardized subject safety and data integrity. 2) Failure to obtain Institutional Review Board (IRB) approval for changes in the research prior to implementing them (21 CFR 312.66), as Protocol 1245.25, Revision 3 (Version 4) with significant inclusion criteria changes was implemented before IRB approval. Dr. Nassim's December 24, 2012, response to the Form FDA 483 was deemed inadequate, lacking sufficient detail on corrective action plans and evidence of IRB approval. The FDA requires a written response within fifteen working days detailing actions taken to prevent future violations, warning that failure to address these deficiencies adequately and promptly may result in further regulatory action.