FDA WARNING_LETTER - Balamurali K. Ambati , M.D., Ph.D. - April 04, 2019

The FDA issued a Warning Letter to Dr. Ambati, a sponsor-investigator, following an inspection conducted from March 25 to April 4, 2019, at their clinical site. The inspection, part of FDA’s Bioresearch Monitoring Program, reviewed Dr. Ambati's conduct of a clinical investigation (Protocol (b)(4)) involving the investigational drug (b)(4). The FDA concluded that Dr. Ambati failed to adhere to applicable statutory requirements and FDA regulations under 21 CFR Part 312 governing clinical investigations. The primary violation identified was the failure to submit an Investigational New Drug (IND) application for the clinical investigation of (b)(4), as required by 21 CFR 312.20(a) and 312.40(a). The drug (b)(4) was studied for (b)(4) and met the definition of a drug, but was not lawfully marketed or exempt from IND requirements. Twelve human subjects were enrolled and treated with this unapproved drug from April 2017 to December 2018 without an IND in effect. Although an IND was subsequently submitted on April 26, 2019, this was deemed inadequate as it occurred after the study's initiation and subject treatment. Dr. Ambati is required to notify the FDA within fifteen working days of actions taken to prevent future violations and ensure compliance with all FDA regulations for ongoing or future studies. Failure to respond adequately may result in further regulatory action.