Why the FDA’s New Plausible Mechanism Pathway Demands a Data Revolution
FDA’s proposed Plausible Mechanism Pathway for bespoke therapies implicitly assumes a robust real‑world data (RWD) and real‑world evidence (RWE) ecosystem 1, even though the article only briefly names it in the context of postmarketing commitments. That ecosystem can be leveraged far earlier in development to de‑risk first‑in‑human interventions, enrich tiny trials, and create cumulative evidence […]
