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. The three-function structure is industry practice built to satisfy those rules, not a process the regulation prescribes: 21 CFR 202.1 says an advertisement may be submitted to the FDA before publication for comment, and makes prior approval compulsory only in narrow circumstances. Inside a company that runs MLR, nothing reaches a customer without passing all three.

Why it matters

MLR is a working precedent for what claim governance looks like when being wrong is a regulatory event rather than a reputational one. It is not the only one: under FINRA Rule 2210 an appropriately qualified registered principal must approve each retail communication before the earlier of its use or filing with FINRA, subject to specified exceptions — among them communications posted on an online interactive electronic forum, and communications that make no financial or investment recommendation and do not otherwise promote a product or service of the member. So financial services runs its own mandatory pre-publication review, without MLR’s three-function split. FINRA proposed in July 2026, in Regulatory Notice 26-14, to replace that pre-use approval requirement with a risk-based standard; comments close on 11 September 2026, and any amendment would still need a separate rule filing with, and approval by, the SEC, so the pre-use requirement stands until that happens. Both regimes are slow and expensive, which is why the pattern stays inside regulated industries. 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. That is the question Knowledge Company exists to answer.