FDA WARNING_LETTER - Birhiray, Ruemu - September 05, 2013

An FDA inspection conducted at Dr. Ruemu E. Birhiray's clinical site between August 12 and September 5, 2013, revealed objectionable conditions regarding the conduct of clinical investigations for the investigational drug (b)(4) (Protocols (b)(4) and (b)(4)). The inspection, part of FDA's Bioresearch Monitoring Program, found that Dr. Birhiray failed to adhere to applicable statutory requirements and FDA regulations. Specifically, two main violations were identified: 1) Failure to ensure investigations were conducted according to the investigational plan (21 CFR 312.60), which included not stopping drug dosing when required, failing to report serious adverse events, and not performing protocol-required study procedures and laboratory tests at specified intervals for multiple subjects. This jeopardized subject safety, especially concerning critical lab monitoring for bisphosphonate compounds. 2) Failure to maintain adequate and accurate case histories (21 CFR 312.62(b)), evidenced by inaccurate recording of subjects' consent to optional future studies and unexplained discrepancies in informed consent documents, raising concerns about subject rights protection. Dr. Birhiray's September 22, 2013, response to the Form FDA 483 was deemed inadequate due to a lack of sufficient detail regarding corrective action plans for future clinical research, including implementation specifics and staff training. The FDA requires a written response within fifteen working days detailing actions taken to prevent similar violations, warning that failure to comply may result in regulatory action.