6 March 2026 - The US FDA will consider several factors when determining whether to accept real world data and real world evidence in regulatory submissions, according to Marie Bradley, senior advisor for real world evidence in the Office of Medical Policy at the Center for Drug Evaluation and Research.

Bradley delved into what FDA looks for in evaluating real world data/real world evidence submissions, as well as the agency’s priorities going forward, at the 2026 RAPS Global Regulatory Strategy Conference on Thursday. These factors include assessing whether the data is appropriate for its intended use, whether the design of the trial or study generating the real world evidence can provide sufficient scientific evidence to address the regulatory question, and whether the study complies with regulatory requirements.

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