FDA Commissioner Martin Makary told a Wall Street audience the agency will increase consideration of real‑world data in regulatory decisions and reiterated calls to modernize early‑phase clinical trial rules. The remarks signal a renewed push for integrating large observational datasets—de‑identified when necessary—into submissions and for streamlining first‑in‑human frameworks to accelerate development while preserving safety. The comments come alongside industry pressure for clearer guidance on AI in trials and signal regulators’ openness to new evidence streams.