Duke-Margolis launches dashboard tracking registry use in FDA decision-making

A new dashboard brings registry-focused real-world evidence use cases into one resource, helping researchers and developers explore how registry data feature in US regulatory decision-making.

The Baseline

• The publicly accessible dashboard brings together registry-focused use cases across the FDA’s drug, biologic and medical device centers.
• It includes registries used alone or alongside other real-world data (RWD) sources.
• Developed using public FDA information, the resource combines data visualizations with AI-supported workflows and human review.

The Duke-Margolis Institute for Health Policy has released its Registry-Focused RWE Use Cases in FDA Decision-Making Dashboard, announcing the resource at the DIA’s 2026 Real-World Evidence Conference this week, where The Evidence Base attended as a media partner.

The tool aims to make examples of registry data use in regulatory contexts easier to identify and explore. By organizing publicly available information in one place, it offers a starting point for evidence teams seeking to understand previous applications and their relevance to future research.

Introducing the dashboard, Rachele Hendricks-Sturrup (Duke-Margolis Institute for Health Policy) described a recurring question from the RWE community: “Where are the use cases? How can we learn from what has been done?”

Although examples appear in peer-reviewed publications, Hendricks-Sturrup highlighted the need for an accessible resource that allows users to visualize and locate cases more easily. Sharing the dashboard in the “spirit of continuing our discussion on open regulatory intelligence,” she connected its development to broader efforts to use publicly accessible information to understand regulatory developments, inform decisions and support transparency around the use of RWE.

Developed with Black Swan Causal Labs, the dashboard draws on the FDA’s published RWE use-case tables and pregnancy exposure registries list, with supplemental metadata obtained through openFDA. Its scope spans the Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), and Center for Devices and Radiological Health (CDRH).

The resource captures use cases in which registry data serve as a source of RWD, either independently or alongside electronic health records, claims and medical records. At the conference, Hendricks-Sturrup reported that the team had identified 298 such cases across the FDA’s drug, biologic and medical device centers, providing a basis for exploring how registry data have featured in different regulatory contexts.

The development process combined AI-supported workflows with human review. According to Hendricks-Sturrup, two independent teams reviewed and checked metadata, with approximately 10% of cases checked against Drugs@FDA records. Feedback from the Duke-Margolis RWE Collaborative and FDA colleagues also informed clarification of information and improvements to visualizations before launch.

The project reflects growing interest in the contribution of registries to regulatory evidence. In December 2023, the FDA issued guidance on assessing registries, setting out considerations for sponsors proposing to use existing registries or establish new ones to support decisions about drug and biological product effectiveness or safety.

For evidence developers, the dashboard offers a route into relevant regulatory examples. Understanding what those examples demonstrate will still require examination of the underlying records, including the question addressed, the contribution of registry data and the wider evidence considered.