FDA WARNING_LETTER - Sabine S. Hazan, M.D. - September 21, 2021

The FDA issued a Warning Letter to Dr. Hazan following an inspection from September 13-21, 2021, as part of the Bioresearch Monitoring Program. The inspection revealed objectionable conditions in the conduct of clinical investigations, specifically a failure to adhere to 21 CFR 312 governing clinical investigations.

The primary violation cited was the failure to assure that an Institutional Review Board (IRB) complying with 21 CFR part 56 was responsible for the initial and continuing review and approval of Protocol (b)(4). IRB approval for this protocol lapsed from (b)(4) to (b)(4). During this lapsed period, ten subjects were enrolled, randomized, and administered investigational drugs ((b)(4)).

Dr. Hazan acknowledged the lapse, attributing it to heightened activity during the COVID-19 pandemic and a lack of other reportable events for the protocol. The FDA emphasized that ensuring continuing IRB review is the investigator's responsibility, regardless of other events or the pandemic.

Corrective actions proposed by Dr. Hazan included notifying affected subjects and reporting these notifications to the IRB. Preventive actions involved hiring a quality control officer/advisor, creating regulatory calendars, implementing monthly staff meetings, and developing an SOP for IRB reports. However, the FDA found the response insufficient, as it did not detail how the clinical investigator would prevent future lapses in IRB continuing review or prevent subject enrollment/drug administration during lapsed approval periods.