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

8 of 251 rules — including rules the source does not limit to any one scope

US-DISC-004·Section VI, Recommendation 3AI-verified
Firm representatives should disclose their firm affiliation in public responses
warningcheckable
US-FB-006·21 CFR 202.1(e)(7)(xi)Disputed
Multi-page Rx ads may lack fair balance if risk info isn't facing/full page
warningcheckable
US-MIS-026·Section V, Recommendation 3AI-verified
Response should include complete reprints and literature, not just firm summaries
warningcheckable
US-NAME-021·Section II.AAI-verified
Established name should sit directly right of or below proprietary name
warningcheckable
US-RISK-020·Section V, Recommendation 6 (A copy of the FDA-required labeling bullet)Disputed
Accompany unsolicited-request response with FDA-required labeling, if any
warningcheckable
US-RISK-023·Section VI, Recommendation 4AI-verified
Public response should include a mechanism to access current FDA-required labeling, if any
warningcheckable
US-SCI-009·Section VI, Recommendation 2AI-verified
Public response should include specific medical/scientific contact information
warningcheckable
US-SCI-010·Section VI, Recommendation 2AI-verified
Detailed off-label response should not be posted publicly in the same forum
warningcheckable