FDA EIR - Axsome Therapeutics, Inc. - July 01, 2026

An FDA surveillance inspection of clinical trial sponsor Axsome Therapeutics, Inc., located in New York, NY, was conducted from June 21 to July 1, 2021. This pre-market inspection, initiated by the Office of Scientific Investigations/CDER, followed compliance program 7348.810 for Sponsors, Contract Research Organizations, and Monitors, as part of the BIMO FY 21 workplan. While no formal FDA Form 483 “Inspectional Observation” was issued, several significant observations were discussed with management. These included the failure to post study results and a protocol on clinicaltrials.gov. For a separate protocol, issues such as paper Case Report Forms (CRFs) lacking complete signatures/initials from transcribers and data changes occurring after principal investigator sign-off were identified. Additionally, the Electronic Data Capture (EDC) system for electronic CRFs lacked full audit trail history for critical events like database lock dates and principal investigator signature invalidation. Finally, two study monitors did not meet the sponsor’s internal qualification requirements. During the close-out meeting, Axsome Therapeutics' CEO stated that the company would not provide a written response to the FDA regarding these discussion items. No refusals were encountered, and no samples were collected.