Regulatory pressure and policy shifts hit the headlines this week as the FDA issued a warning letter to Novo Nordisk over quality issues at a Catalent‑acquired Bloomington, IN, manufacturing site, asking the company to analyze all Catalent sites it acquired. The letter highlights post‑acquisition manufacturing and compliance risks that can ripple across supply chains. In parallel, the FDA announced a more permissive stance on using real‑world evidence (RWE) in device premarket reviews, easing constraints around data sources lacking patient‑level records. The two moves underscore a regulatory landscape where agencies balance stricter manufacturing oversight with pragmatic acceptance of diverse evidence streams to accelerate approvals.