The U.S. Food and Drug Administration’s (FDA’s) Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) are aware of challenges sponsors encounter in submitting patient-level data for real-world data (RWD) analyzed as part of clinical studies in a marketing application. These challenges relate to data ownership, privacy requirements (including HIPAA and GDPR), and data-use agreements.