Myovant Sciences, Inc. – FDA EIR, Jun 30, 2020

An FDA comprehensive establishment inspection was conducted at Myovant Sciences, Inc. in Brisbane, CA, from June 23 to June 30, 2020. This high-priority inspection, initiated under compliance program 7348.810 for "Sponsor/Monitors," focused on data integrity surveillance related to a New Drug Application (NDA #214621). The primary objective was to assess the company's practices and procedures as a sponsor of a clinical study, ensuring adherence to the investigational plan, relevant FDA regulations, and Good Clinical Practices, particularly concerning its oversight of contracted services. The inspection involved a detailed review of the clinical study, which encompassed 934 enrolled subjects across 155 sites in 21 countries. Review included investigator agreements, financial disclosure forms, informed consent processes, adverse event reporting, and monitoring records for a random selection of ten sites. Crucially, the inspection concluded without any significant deviations from Federal Regulations or the study protocol being observed. Consequently, no Form FDA-483, "INSPECTIONAL OBSERVATIONS," was issued, indicating a compliant outcome. No specific regulatory actions were required from Myovant Sciences, Inc. following this inspection.