FDA EIR - Gilead Sciences, Inc. - August 18, 2020

An FDA inspection of Gilead Sciences, Inc. in Foster City, CA, was conducted from August 6-18, 2020, as a hybrid onsite and remote review due to the COVID-19 pandemic. This high-priority Bioresearch Monitoring (BIMO) inspection, conducted under FDA Compliance Program 7348.810 and Good Clinical Practice (GCP) principles, focused on New Drug Application (NDA) 214787 for the investigational drug Remdesivir, specifically Protocols GS-US-540-5773 and GS-US-540-5774. While no FDA Form 483 (Inspectional Observations) was issued during this specific inspection, several "Discussion Items" were raised with management. Key observations included a discrepancy between contractual agreements (Transfer of Regulatory Obligation Agreements vs. Work Orders) regarding responsibility for medical monitoring at international clinical sites. Additionally, documentation for investigator and research staff training at a reviewed clinical site (Dr. Mullane's) for both protocols was found inadequate, showing inconsistencies in attendance records and a lack of proper source documentation for training sessions and protocol amendments. Another point of discussion involved the remote review process for informed consent forms (ICFs), where Clinical Research Associates (CRAs) relied on site staff reading out documentation details instead of direct visual verification due to patient privacy concerns. These discussions highlight areas for potential procedural enhancement in clinical trial oversight and documentation practices under the Food, Drug, and Cosmetic Act (FD&C Act).