FDA EIR - Julie Hoover-Fong, M.D. - November 06, 2020

An FDA inspection of clinical investigator Julie Hoover-Fong, M.D., located in Baltimore, MD, was conducted from November 3 to November 6, 2020. This comprehensive review, under the Bioresearch Monitoring Clinical Investigator program (CP 7348.811) and Prescription Drug User Fee Act (PDUFA), focused on three protocols for vosoritide (BMN 111) sponsored by BioMarin Pharmaceuticals. The inspection covered regulatory binders, informed consent forms, subject records, and the pharmacy area. Key discussion items and issues identified included discrepancies in adverse event (AE) reporting. Specifically, one subject's emotional outburst AE form lacked complete information in the source document, despite being fully recorded in the electronic case report form (eCRF). Another subject's AE dates were transcribed incorrectly between the source log and eCRF, and two AEs for a third subject were recorded in source logs but not entered into the eCRF. An instance of two subjects initially signing an unapproved informed consent form, though later re-consented, was also noted. The investigational product refrigeration thermometer clock was found unreset after daylight saving time. No formal FDA-483 observations were issued. Management, Dr. Hoover-Fong, acknowledged these issues and committed to implementing corrections, including ensuring all AE data is complete and accurately transcribed, addressing missing entries in the eCRF, and reinforcing data entry verification with the study team and monitors. These actions aim to enhance data integrity and compliance with study protocols.