Flatiron expands real-world data partnership with FDA

Just months after FDA Commissioner Scott Gottlieb called real-world evidence a "top strategic priority," the agency has expanded a partnership with Flatiron Health Inc. to better understand how the data can support regulatory decision-making.

In December, FDA released its RWE framework, which envisioned using data from electronic health records (EHRs), observational and pragmatic studies, and mobile or wearable devices to support approvals of new indications for approved drugs, and for satisfying postapproval study requirements (see "FDA Releases Real-World Evidence Framework")...