Every finding cites a rule.
Every rule cites its source.
This is the rule brain behind MLRagent — open for you to read, question and audit. Each rule quotes the regulation or FDA guidance it comes from, word for word, and shows how far it has been checked. There is no single industry-wide MLR standard; this is the shared regulatory floor, written down.
How a rule earns trust
No rule is used in a review until it has been independently verified. The badge on every rule tells you exactly how far it has come — we would rather show you an honest “AI-verified” than claim a person checked everything.
Citation proven by script. Not yet independently verified — not used in reviews.
Citation proven by script and passed an independent verifier running on a different model. Not yet confirmed by a human.
Citation proven by script, passed an independent AI verifier, and confirmed by a human reviewer.
37 rule(s) are disputed — the drafting and verifying models could not agree, so a person will decide. They are not used in reviews.
Start from the kind of piece
A framework is a scope, not a hand-picked list: it contains every rule whose source does not rule it out for that kind of piece.
Print, broadcast and digital advertising aimed at patients and the public for an approved product. Adds the consumer-specific requirements: brief summary, and for TV and radio the major statement presented in a clear, conspicuous and neutral manner. This is where FDA's 2025 enforcement wave landed.
Sales aids, leave-behinds, detail pieces, congress booth panels, HCP emails and websites for an approved product. The everyday work of an agency medical writer on the commercial side (PRC review). Consumer-only rules — the DTC major statement, for example — are out of scope.
Anything about an investigational product, or an investigational use of an approved one. No representation that it is safe or effective, and no commercialization — while genuine scientific exchange stays open. Disease-state communication lives here.
Browse by what the rule is about
Balance between effectiveness claims and risk information — prominence, proximity, completeness.
Required risk content is present — brief summary, major statement, side effects, contraindications, boxed warning.
Claims stay within the approved labeling — indication, population, dose; broadening; consistency with labeling.
Effectiveness and safety claims are supported by adequate evidence; evidence is represented accurately.
Comparisons with other drugs — superiority, safety advantage, hanging comparisons.
How information is presented — statistics, graphics, selective quotation, literature use, headlines, distraction.
Proprietary and established name placement and prominence; ingredient and quantitative information.
What must be submitted to FDA, when, and how — Form FDA 2253, pre-dissemination review, formats.
Promotion of investigational products or uses before approval.
Non-promotional communication — unapproved-use scientific information, unsolicited requests, reprints, CME.
Health care economic information and communications to payors and formulary committees.
Required statements, disclaimers and disclosures not covered above.
When a rule applies
A rule only fires when the piece is in its scope — and its scope is only ever what the source itself says. These are the distinctions the sources have actually drawn so far.
MLRagent is a pre-check. It does not give legal advice, certify compliance, or replace your MLR or PRC committee. Rules marked “needs human judgment” are only ever raised as questions for a person to decide.