FDA official offers insights on agency’s criteria for RWD in regulatory submissions
BALTIMORE – The US Food and Drug Administration (FDA) will consider several factors when determining whether to accept real-world data (RWD) and real-world evidence (RWE) in regulatory submissions, according to Marie Bradley, senior advisor for RWE in the Office of Medical Policy at the Center for Drug Evaluation and Research (CDER).Bradley delved into what FDA looks for in evaluating RWD/RWE submissions, as well as the agency’s priorities going forward, at the 2026 RAPS Global Regulatory Strategy (GRS) 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.
Erin Grath, associate vice-president of Agilent Technologies, who moderated the discussion, noted that “randomized clinical trials remain foundational, but the expanded availability of real-world-data offers powerful opportunities to complement a traditional evidence-based approach and inform regulatory decisions.”
Bradley said FDA has been active in the RWD/RWE space beginning in December 2016 with the passage of the 21st Century Cures Act which mandated that the FDA establish a program for evaluating this data in its regulatory decision-making, and the program has since evolved. The latest action was in September 2025 when FDA established the RWE Accelerate program, a unified approach to guide RWE efforts across the agency and address the complexities of RWE generations.
In recent years, the FDA has also issued multiple draft and final guidance documents to help sponsors use RWD/RWE. These include guidance on electronic health records (EHRs) and claims data, registries, data standards, and considerations for using use of RWD/RWE and noninterventional studies (NIS) for regulatory decision-making.
CDER has approved eight new drug applications (NDAs) that incorporated RWE and has approved 26 safety-related labeling changes with this data by the end of September 2025. Meanwhile, FDA’s Center for Biologics Evaluation and Research (CBER) granted approval for four biologics license applications (BLAs) that included RWE elements and approved 10 safety-related labeling changes with this data.
Bradley said that some of the challenges with using real-world data sources include data reliability and clinical relevance and whether outcome data has been suitably captured.
Some of her recommendations for getting RWD requests approved are to consult with FDA “early and often” when considering the use of RWD. Sponsors should also ensure all analyses are pre-specified in a protocol and statistical analysis plan (SAP) reviewed by FDA before starting the study. Additionally, sponsors should ensure that patient-level data are available for review and traceable to the source.
Grath asked Bradley how FDA’s CDER plans to advance its work in the RWE/RWD field over the next three to five years.
Bradley responded that “I alluded to the whole data quality thing. You have to demonstrate that your data source is relevant and reliable.”
A second priority is for FDA to advance research in this area. “In other spaces, we have a large portfolio of demonstration research projects that we fund with academic and technology companies to explore methodologies in these spaces,” Bradley said.
A third priority is advancing data standards for RWE/RWD. Bradley noted that last April 2025, FDA published a Federal Register notice requesting public comment on using Health Level Seven (HL7) Fast Healthcare Interoperability Resources (FHIR) standards for structuring this data in regulatory submissions. The initiative aims to modernize how RWD is collected and submitted.
RAPS Global Regulatory Strategy Conference
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