FDA EIR - Adam D. Cohen, MD - January 10, 2020

An FDA inspection of clinical investigator Adam D. Cohen, MD, located in Philadelphia, PA, was conducted from January 6-10, 2020. This comprehensive, initial inspection, carried out under the regulatory framework of Compliance Program Guidance Manual 7348.811 for Clinical Investigators and Sponsor-Investigators, focused on Protocol 205678, a Phase II open-label study investigating the efficacy and safety of GSK2857916 in participants with multiple myeloma. The inspection evaluated various critical aspects of clinical trial conduct, including Institutional Review Board (IRB) initial and continuing review, Forms FDA 1572, financial disclosure, site staff training, delegation of authority, subject eligibility, informed consent processes, investigational product accountability, adverse event reporting, and overall compliance with the study protocol. Following a thorough review of records and procedures, the FDA found no objectionable conditions or significant issues. Consequently, no Form FDA 483 (Inspectional Observations) was issued, and no verbal discussion items were raised, indicating full compliance with regulatory requirements for clinical investigations. The only required action was the administrative issuance of the Establishment Inspection Report (EIR) to Dr. Cohen.