Two regulatory shifts this week add both permissiveness and pressure across biopharma compliance. The FDA issued final guidance that relaxes restrictions on using de‑identified real‑world evidence (RWE) in premarket device submissions and signaled similar openness for drugs, easing barriers for observational data in regulatory decisions. Concurrently, a DOJ‑HHS interagency working group is broadening False Claims Act enforcement to target a wider array of life‑sciences practices, including Medicare Advantage billing, kickbacks, and product quality issues. Legal advisors warned compliance officers to brace for expanded litigation risk and to tighten documentation, quality control, and AI governance. Together the moves create a paradox: regulators are more receptive to RWE in approvals but are simultaneously increasing enforcement reach. Biotech and med‑tech firms must balance accelerated evidence strategies with reinforced compliance programs to manage heightened legal exposure.