MLR Review

What it is

MLR review is the medical, legal and regulatory sign-off that life-sciences companies require before any external-facing claim is published. Medical reviewers check that the science supports the statement, legal checks promotion law and intellectual property, and regulatory checks labelling and advertising rules such as 21 CFR 202.1. Nothing reaches a customer without passing all three.

Why it matters

MLR is the closest working precedent for what claim governance looks like when being wrong is a regulatory event rather than a reputational one. It is also slow and expensive, which is why no other industry has adopted it wholesale. The useful question is not whether to copy it but which parts of it — the claim-level granularity, the evidence link, the expiry — can be made automatic enough to be worth running outside a regulated market.