FDA Commissioner Marty Makary told a Wall Street audience the agency will consider more real‑world data (RWD) in drug and device applications, including large de‑identified datasets, and reiterated calls to reform early‑phase clinical trials. Makary emphasized integrating RWD to supplement traditional evidence and urged modernization of early‑phase designs to speed development while maintaining safety. The FDA’s public remarks suggest regulators will continue expanding the evidentiary framework that accepts observational and decentralized data sources. Sponsors should anticipate increased dialogue on data provenance, statistical methods, and transparency when proposing RWD to support labeling or approvals. Real‑world data refers to routinely collected health data outside randomized trials — such as claims, EHR, and registries — and agencies will expect rigorous validation and reproducible analytic approaches when it informs regulatory decisions.