Marian E. Shaw, MD – FDA 483, Jan 27, 2025

An FDA inspection of Marian E. Shaw, MD, a clinical investigator for Novavax, Inc., revealed significant deficiencies in the conduct of a clinical trial. Observations included failures to maintain adequate case histories by not verifying subject eligibility with medical records, relying instead on verbal confirmation. Additionally, the investigator administered study materials after a temperature excursion without prior sponsor approval and failed to obtain Institutional Review Board approval for these protocol deviations.