FDA WARNING_LETTER - Laveeza (nmi) Bhatti, M.D., Principle Investigator - December 16, 2016

On August 4, 2017, the FDA issued a Warning Letter to Laveeza Bhatti, M.D., Ph.D., following an inspection from October 27 to December 16, 2016. The inspection, part of the Bioresearch Monitoring Program, evaluated Dr. Bhatti's conduct of clinical investigations for the investigational drug (b)(4) in protocols (b)(4) and (b)(4).

The letter identified two main violations:

1. **Failure to ensure the investigation was conducted according to the investigational plan [21 CFR 312.60]:** * **Ineligible Subject Enrollment:** * Subject 492 ((b)(4) protocol) was enrolled despite a screening ECG showing a QRS duration of 138 msec, exceeding the exclusion criterion of >120 msec. * Subject 498 ((b)(4) protocol) was randomized and received study drug with baseline QTc intervals of 509-525 msec, exceeding the exclusion criterion of >450 msec. Dr. Bhatti acknowledged administering one dose before reviewing ECGs and subsequently withdrew the subject. * Subject 19 ((b)(4) protocol) was enrolled despite prior exposure to an (b)(4) agent, which was an exclusion criterion.