Regulatory Strategies

February 2026. A 47-page draft guidance drops on the FDA website. No press conference. No industry call. Just a PDF that rewrites the approval playbook for every sponsor running a pivotal program. The new default: one adequate and well-controlled study, combined with confirmatory evidence, is sufficient for marketing authorization. One. Not two. That’s the end

FDA’s Real-World Evidence Shift Is Bigger Than You Think — What It Means for Your Next Submission In December 2025, the FDA finalized updated guidance on Real-World Evidence (RWE) for regulatory decision-making. It replaced the 2017 version entirely. Most product development executives have barely noticed. That’s a mistake. This isn’t a guidance refresh. It’s a