The US Food and Drug Administration (FDA) recently published a comprehensive overview of how real-world evidence (RWE) has contributed to regulatory decision-making since 2011.
The new webpage, built by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER), catalogs more than a decade of case studies where RWE supported approvals, safety communications, and labeling updates.
This initiative signals a growing acceptance of RWE as a trusted and standard tool for informing high-stakes, regulatory decisions, and a rising expectation that evidence be transparent, reproducible, and fit-for-purpose.
A transparent view of RWE in action
The FDA’s new resource provides visibility into how evidence from electronic health records, registries, and claims has been used to expand labels, strengthen safety communications, and support approvals when randomized trials were infeasible. From pediatric therapies to rare diseases, the case studies underscore both the promise of RWE and the bar that sponsors must meet for rigor and reliability.
Transparency sits at the center of this shift. Regulators want clear answers not just on what the data show, but where the data come from and how the evidence was generated.
What we heard at CDER’s RWE convening
How Truveta delivers trusted, regulatory-grade RWE
Truveta has made deep, sustained investments to ensure our data meet the most stringent regulatory-grade standards. We provide regulatory-grade data that is directly traceable to its source, fully auditable, and trusted by regulators.
Transparency and audit readiness
- All data and regulatory artifacts are stored with secure versioning, read-only exports, and logged evidence proving system integrity — readily available for audit.
- Every clinical concept from notes is accompanied by documentation of definitions, modeling methods, and extraction performance, designed to be shared in submissions.
- Truveta Studio’s audit-ready workflows power transparent, interactive studies that go exceed regulatory standards, with complete traceability across every line of code and data transformation step.
- Direct partnerships with US health systems ensure complete provenance of every data point.
Trusted processes validated by experts
- Truveta Data is trusted and used in regulatory decision-making by the FDA.
- Truveta has earned Type 2 SOC 2 examination and ISO 27001 certification, with ISO 27018 and 27701 extensions, with additional certifications underway. These certifications serve as external validation that Truveta’s controls, protocols and processes align with rigorous standards for both security and privacy.
Research services team
- A dedicated group providing professional services for post-marketing commitments (PMCs/PMRs), post-authorization safety studies (PASS/PAES), and label expansions. with experience spanning 170+ publications, nearly 11,000 citations, 200+ conference presentations, and dozens of regulatory projects across US and global agencies.
- Extensive experience spanning post-marketing commitments (PMCs/PMRs), post-authorization safety studies (PASS/PAES), and label expansions.
- Work accelerates study design and delivery with transparent, end-to-end support, generating evidence regulators trust.
Scale and representativeness
- The most complete, real-time, and trusted EHR data from more than 120M patients, including 1 in 3 Americans, linked with 200M closed claims, mortality, and social drivers of health.
- Rich clinical detail spanning 7B+ notes, 100M+ imaging studies, 45M+ device uses, and 1.4M mother–child pairs
- Refreshed daily to capture patient journeys in real-time, far outpacing outdated registries and other real-world datasets.
Looking ahead
RWE is becoming central to regulatory decisions. Regulators have shown their reliance on it; now industry must meet the moment with evidence that meets the highest standards of quality, transparency, and reproducibility.
Truveta delivers regulatory-grade, real-world data that power breakthrough discoveries, accelerates submissions, and unlocks real-time insights.
Schedule a demo today to see how Truveta supports regulatory submissions.