MLRagent

Rules

Aboutfair balancerisk disclosureindication on labelsubstantiationcomparativemisleading presentationname ingredientsubmissionpre approvalscientific exchangedisclosure
TrustAI-verifiedDisputedDraft
Severityblockerwarningnote
Decided bya checkhuman judgment
Naturepromotional
Basisconsistent-with-labelingunsolicited-requestunapproved-use-scientific
Audiencehcpconsumer
Document typeadvertisement
Risk info placementdistinct-part
Communication typeadvertisement
Mediumprintbroadcastdigitalsocialin-person
Regulatory classprescription-drug
Material typeprescription-drug-advertisementadvertisement
Launch stagepost-approvalpre-approval
Productdrugbiologicprescription-drug
Drug classprescription
Rx statusprescription
Advertising typeprescription-drug-advertisement
Populationhuman-use
Content triggerliterature-or-study-effectiveness-claim
Materialadvertisement
Content typeadvertisement
Active ingredient counttwo-or-more
Proprietary name basismixture-designation
Established name statusnone-for-mixture-designation
Drug classificationprescription
Labeling scenariosingle-proprietary-name-multiple-preparations-no-established-name
Prescription statusprescription-drug
Ad exemptionexcludes-reminder-adsexcludes-bulk-sale-drug-adsexcludes-prescription-compounding-drug-ads
Ad formattelevision
Intended specieshuman
Exemption statusnon-exempt
Approval pathwayaccelerated

3 of 251 rules

US-CMP-001·21 CFR 202.1(e)(6)(ii)AI-verified
No unsubstantiated drug-to-drug safety/effectiveness comparison
blockerneeds human judgment
US-CMP-002·21 CFR 202.1(e)(6)(xvi)AI-verified
No superiority suggestion via 'does not contain'/potency claims absent adequate support
blockerneeds human judgment
US-CMP-003·Q.10/A.10, Example 2AI-verified
Superiority claims require a study designed to establish superiority
blockerneeds human judgment